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66--Surgical and Medical Instruments

Solicitation Number: W81NWY82948426
Agency: Department of the Army
Office: U.S. Army Medical Command
Location: Great Plains Regional Contracting Ofc
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W81NWY82948426
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Combined Synopsis/Solicitation
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Added: Jan 07, 2009 1:40 pm
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. Solicitation W81NWY82948426 is issued as a request for quotation (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-05. This acquisition is unrestricted under NAICS code 339112 and the business size standard is 500 employees. Federal Acquisition Regulation (FAR) Clause 52.211-6 Brand Name or Equal applies to this acquisition. The requirements in this solicitation are:

CLIN 0001 Quantity Unit Unit Price
7 ea
KyphoPak Express 10/2 First Fx Tray
KyphoPak Express 10/2 First Fx Tray, KPE1001, EA
FOB: Destination
NSN: KPE1001

CLIN 0002 Quantity Unit Unit Price
4 ea _________
KyphoPak Express 10/2 Add'l Fx Tray
KyphoPak Express 10/2 Add'l Fx Tray, KPE1002
FOB: Destination
NSN: KPE1002

CLIN 0003 Quantity Unit Unit Price
2 ea ________
KyphoPak OIS 15/3 First Fx Tray
KyphoPak OIS 15/3 First Fx Tray, KPT1502,
FOB: Destination
NSN: KPT1502

CLIN 0004 Quantity Unit Unit Price
12 ea _________
KyphoPak One-Step 15/3 First Fx Tray
KyphoPak One-Step 15/3 First Fx Tray, KPT1505,
FOB: Destination
NSN: KPT1505

CLIN 0005 Quantity Unit Unit Price
8 ea ________
KyphoPak 15/3 Additional Fx Tray
KyphoPak 15/3 Additional Fx Tray, KPT1504,
FOB: Destination
NSN: KPT1504

CLIN 0006 Quantity Unit Unit Price
2 ea ________
KyphoPak OIS 20/3 First Fx Tray
KyphoPak OIS 20/3 First Fx Tray, KPT2002,
FOB: Destination
NSN: KPT2002

CLIN 0007 Quantity Unit Unit Price

12 ea ________
KyphoPak One-Step 20/3 First Fx Tray
KyphoPak One-Step 20/3 First Fx Tray, KPT2005,
FOB: Destination
NSN: KPT2005

CLIN 0008 Quantity Unit Unit Price
8 ea _________
KyphoPak 20/3 Additional Fx Tray
KyphoPak 20/3 Additional Fx Tray,KPT2004,
FOB: Destination
NSN: KPT2004

CLIN 0009 Quantity Unit Unit Price
55 ea _________
KyphX HVR Cement/Mixer Kit
KyphX HVR Cement/Mixer Kit, C01B,
FOB: Destination
NSN: C01B

CLIN 0010 Quantity Unit Unit Price
7 ea ________
KyphX Lattitude Curette 8mm T-Tip
KyphX Lattitude Curette 8mm T-Tip, A11B,
FOB: Destination
NSN: A11B

CLIN 0011 Quantity Unit Unit Price
3 ea _________
KyphX Express Size 2 Bone Biopsy Device
KyphX Express Size 2 Bone Biopsy Device, F07A ,
FOB: Destination
NSN: F07A

CLIN 0012 Quantity Unit Unit Price
10 ea __________
KyphX Size 3 Bone Biopsy Device
KyphX Size 3 Bone Biopsy Device, F05A,
FOB: Destination
NSN: F05A


Salient Characteristics:

(1) KPE1001 KyphoPak Express 10/2 First Fx Tray-(T24A) Kyphx express osteo introducer system, integrated one-step design, 10gauge (3.4 mm) working canula, diamond or beveled trocar tip. (K15A) inflatable bone tamp, length 10 mm, working cannula diameter 3.4 mm, PSI rating 400, maximum diameter 15.5 mm, maximum length 21.1 mm, maximum volume 4 cc. (F06A) KyphX express bone filler device, tapered design allows maximum volume bone cement delivery in a control low-pressure manner, 1.0 cc volume delivery. (A08A) KyphX Xpander inflation syringe.

(2) KPE1002 KyphoPak Express 10/2 Addl Fx Tray- (K15A) inflatable bone tamp, length 10 mm, working cannula diameter 3.4 mm, PSI rating 400, maximum diameter 15.5 mm, maximum length 21.1 mm, maximum volume 4 cc. (F06A) KyphX express bone filler device, tapered design allows maximum volume bone cement delivery in a control low-pressure manner, 1.0 cc volume delivery.

(3) KPE1002 KyphoPak Express 10/2 Addl Fx Tray- (K15A) inflatable bone tamp, length 10 mm, working cannula diameter 3.4 mm, PSI rating 400, maximum diameter 15.5 mm, maximum length 21.1 mm, maximum volume 4 cc. (F06A) KyphX express bone filler device, tapered design allows maximum volume bone cement delivery in a control low-pressure manner, 1.0 cc volume delivery.

(4) KPT1505 KyphoPak One-Step 15/3 First Fx Tray- (T05J) KyphX one-step osteo introducer system-single step access and channel creation no instrument exchanges, available in trocar, diamond or beveled tip. (K09A) KyphX Xpander inflatable bone tamp 15/3, maximum inflation volume 4 ml, maximum inflation pressure 400 psi, maximum length 19.7 mm, maximum diameter 14.3 mm, maximum volume 4 ml. (F04B) KyphX Bone filler devise- nozzle and plunger design provides tactile feedback, has three 1 cm nozzle position markers, plunger position markers to indicate volume of bone cement delivered. (A08A) KyphX Xpander inflation syringe.

(5) KPT1504 KyphoPak Addl 15/3 First Fx Tray- (K09A) KyphX Xpander inflatable bone tamp 15/3, maximum inflation volume 4 ml, maximum inflation pressure 400 psi, maximum length 19.7 mm, maximum diameter 14.3 mm, maximum volume 4 ml. (F04B) KyphX Bone filler devise- nozzle and plunger design provides tactile feedback, has three 1 cm nozzle position markers, plunger position markers to indicate volume of bone cement delivered.

(6) KPT2002 KyphoPak OIS 20/3 First Fx Tray- Kyphon 11gauge bone access needle, (T05D) KyphX osteo introducer system, combination blunt dissector stylet and working cannula, 4-facet tip design improves communication with cannula. (K08A) KyphX Xpander inflatable bone tamp 20/3, maximum inflation volume 6 ml, maximum inflation pressure 400 psi, maximum length 28.2mm, maximum diameter 15.8 mm, maximum volume 6 ml. (F04B) KyphX Bone filler devise- nozzle and plunger design provides tactile feedback, has three 1 cm nozzle position markers, plunger position markers to indicate volume of bone cement delivered. (A08A) KyphX Xpander inflation syringe.

(7) KPT2005 KyphoPak One-Step 20/3 First Fx Tray- (T05J) KyphX one-step osteo introducer system-single step access and channel creation no instrument exchanges, available in trocar, diamond or beveled tip, (K08A) KyphX Xpander inflatable bone tamp 20/3, maximum inflation volume 6 ml, maximum inflation pressure 400 psi, maximum length 28.2mm, maximum diameter 15.8 mm, maximum volume 6 ml. (F04B) KyphX Bone filler devise- nozzle and plunger design provides tactile feedback, has three 1 cm nozzle position markers, plunger position markers to indicate volume of bone cement delivered. (A08A) KyphX Xpander inflation syringe.

(8) KPT2004 KyphoPak Addl 20/3 First Fx Tray- (K08A) KyphX Xpander inflatable bone tamp 20/3, maximum inflation volume 6 ml, maximum inflation pressure 400 psi, maximum length 28.2mm, maximum diameter 15.8 mm, maximum volume 6 ml. (F04B) KyphX Bone filler devise- nozzle and plunger design provides tactile feedback, has three 1 cm nozzle position markers, plunger position markers to indicate volume of bone cement delivered.

(9) C01B KyphX HVR Cement Mixer Kit- Graduated marking, for direct measurement of ingredients; Luer fitting, allows for one-step mix and transfer of cement to KyphX bone filler devices and standard syringe; Self-venting plunger, allows for air-purging prior to cement transfer; capacity for mixing 20 grams of powder polymer; Cement has approximately 8 min of working time; Controlled delivery in high-viscosity doughy state; for radiopacity it contains 30% Barium Sulfate.

(10) A11B KyphX Latitude Curette 8MM T-Tip- lever handle, locking mechanism locks tip at 0, 30, 60, and 90, degree indicator indicates angle of tip deployment, T-tip configuration symmetrical cone design facilitates uniform scoring action in all directions, wedge tip configuration designed for scoring grooves or channels, UniLink Inner construction dual tip attachment mechanism pivot pin plus UniLink actuator loop for durability and control, score line of shaft designed to disengage UniLink actuator for complete device removal, shaft exit marker exit marker on shaft aligns with proximal end of cannula to indicate when curette tip is at distal edge of cannula, cannula stop collar on shaft provides physical stop to prevent curette tip from extending more that 3.7 cm past distal edge of cannula.

(11) F07A KyphX Express Size 2 Bone Biopsy Device- conical cutting tip, smaller diameter 13gauge (2.4 mm).

(12) F05A KyphX Size 3 Bone Biopsy Device- conical cutting tip designed to cut clearly through cancellous bone for easy specimen collection, plunger allows easy delivery of biopsy sample from device.

This requirement is for the Brooke Army Medical Center, Fort Sam Houston, Texas. Federal Acquisition Regulation (FAR) Clauses can be viewed by accessing website http://farsite.hill.af.mil/. FAR provision 52.212-1 [Instructions to Offerors Commercial] applies to this acquisition to include the following addenda: All offerors are cautioned that if selected for award, they must be registered with the Central Contractor Registration (CCR) program. The CCR can be accessed via the internet at www.ccr.gov/. Confirmation of CCR registration will be validated prior to awarding a contract. The Government will award a single-contract, resulting from this solicitation, to the responsible offeror whose offer, conforming to the solicitation, is Lowest Priced, Technically Acceptable (LPTA). The following factors shall be used to evaluate offers: Technical Capability and Price. Technical Capability: Explain how your company will meet all the salient characteristics 1 through 12 as specified in the Solicitation; (NOTE): Statements that the offeror understands, can or will comply with all specifications, or statements paraphrasing the specifications or parts thereof, or phrases such as standard procedures will be used or well known techniques will be used will be considered insufficient. Price. Award will be all or none basis. Evaluation Process: All quotes will be evaluated on Technical Acceptability. The Award decision will be based on the Lowest Priced, Technically Acceptable quote. FAR 52.211-6 [Brand Name or Equal]; 52.212-2 [EvaluationCommercial Items]; Vendors shall include a completed copy of FAR provision 52.212-3 with their offer. The provision can be downloaded by accessing the FAR clause 52.212-4 [Contract Terms and Conditions Commercial Items] applies to this acquisition to include the following addenda: Defense Federal Acquisition Regulation Supplement (DFARS) 252.232-7003 Electronic Submission of Payment Requests and DFARS 252.211-7003. FAR Clause 52.212-5 [Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items] applies to this acquisition and the following sub FAR Clauses apply: 52.203-6 [Restrictions on Subcontractor Sales to the Government]; [52.217-9 Option To Extend the Term of the Contract (MAR 2000)]; 52.222-3 [Convict Labor]; 52.222-19 [Child Labor Cooperation with Authorities and Remedies]; 52.222-21 [Prohibition of Segregated Facilities] 52.222-26 [Equal Opportunity]; 52.222-35 [Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans]; 52.222-36 [Affirmative Action for Workers with Disabilities]; Registration]; and 52.232-36 [Payment by Third Party]. (a) The total duration of this contract, shall not exceed 8 months. The closing date and time of this solicitation is 16 January 2009, 11:00 A.M. Central Standard time. Quotes shall be submitted on company letterhead and signed by a company representative. Fax quotes to Great Plains Regional Contracting Office (210) 221-2539 Paper copies of this solicitation will not be issued and telephone requests or FAX requests for the solicitation will not be accepted. Point of contact for this solicitation: Roland Jasso, phone (210) 221-4964; e-mail roland.jasso3@amedd.army.mil


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Great Plains Regional Contracting Ofc, ATTN: MCAA GP L31 9V, 3851 Roger Brooke Drive, Fort Sam Houston, TX 78234-6200
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Great Plains Regional Contracting Ofc ATTN: MCAA GP L31 9V, 3851 Roger Brooke Drive Fort Sam Houston TX
78234-6200
US
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Roland Jasso, 210-221-4964

Great Plains Regional Contracting Ofc