MODIFICATION
65 -- GI Hemostatic Clips
- Notice Date
- 11/30/2018
- Notice Type
- Modification
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- U.S. Department of Veterans Affairs;OPAL | Strategic Acquisition Center;10300 Spotsylvania Ave | STE 400;Fredericksburg VA 22408-2697
- ZIP Code
- 22408-2697
- Solicitation Number
- 36C10G18R0140
- Response Due
- 12/11/2018
- Archive Date
- 1/10/2019
- Point of Contact
- cynthia.washington2@va.gov
- Small Business Set-Aside
- N/A
- Description
- Page 2 of 2 The Strategic Acquisition Center anticipate awarding a single Firm Fixed Price Indefinite Delivery Indefinite Quantity enterprise-wide contract for Gastrointestinal Hemostasis Clips. The Request for Proposals is anticipated to be posted on FedBizOps on or about 14 December 2018. Below are the Minimum Technical Requirements for this Action: CLIN 0001 Gastrointestinal (GI) Hemostatic Clips Long TECHNICAL SPECIFICATIONS METHOD OF EVALUATION MTR 1 Shall have a minimum working length of 230 centimeters (cm) Physical Inspection / Literature Review MTR 2 Shall have a minimum outside dimension clip opening of 9 millimeters (mm) Physical Inspection / Literature Review MTR 3 Shall have a minimum accessory channel size of 2.8 mm Physical Inspection / Literature Review MTR 4 Clip shall open, close, and reopen without deploying Physical Inspection / Literature Review MTR 5 Packaging or literature must specify the clip is Magnetic Resonance Imaging (MRI) Safe, or MRI Conditional with the conditions for use specified. (See ASTM F2503-13 Standard Practice for Making Medical Devices and other Items for Safety in the Magnetic Resonance Environment) Physical Inspection / Literature Review MTR 6 Jaw shall be rotatable a minimum of 180 degrees of arc clockwise and counter clockwise Physical Inspection / Literature Review MTR 7 Must be composed of hypo allergic materials with a clip composed of metal or alloy(s) designated for medical applications Physical Inspection / Literature Review MTR 8 The packaging must state that the device is sterile Physical Inspection of individual packaging MTR 9 Must be latex-free or made without natural rubber Physical Inspection / Literature Review MTR 10 Packaging must state that the device is single patient usage Physical Inspection of individual packaging MTR 11 Packaging must state the expiration date Physical Inspection of individual packaging MTR 12 Packaging must state the lot number Physical Inspection of individual packaging MTR 13 Must be United States Food and Drug Administration (FDA) approved Literature Review MTR 14 Shall have a tactile indication/positive feedback upon clip deployment (e.g., can hear or feel the deployment) Physical Inspection MTR 15 Device must be preassembled and ready for use Physical Inspection / Literature review MTR 16 Warranty: The Contractor(s) shall provide warranty of the workmanship against defects. Defective items will be replaced upon discovery. Literature review Intended Use: Devices used for Endoscopic marking and Hemostasis (End of Presolicitation Notice) NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (30-NOV-2018); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/notices/d2ac6313ff3f26284606d65341ac0990)
- Record
- SN05164257-F 20181202/181130230044 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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