AccessGUDID - DEVICE: GORE-TEX Vascular Graft (00733132610365)

GUDID

Device Identifier (DI) Information

Brand Name: GORE-TEX Vascular Graft
Version or Model: R08012030L
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: R08012030L
Company Name: W. L. Gore & Associates, Inc.

Primary DI Number: 00733132610365
Issuing Agency: GS1
Commercial Distribution End Date: September 18, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 967358115 *Terms of Use

Device Description: RG 8MM 12CM RS X 30CM

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35281	Synthetic vascular graft	An implantable artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DSY	PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K811510	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 30 Centimeter
Lumen/Inner Diameter: 8 Millimeter

Device Record Status

Public Device Record Key: 435aadbc-0e43-48f3-a154-ec1e303c5c30
Public Version Date: March 26, 2025
Public Version Number: 6
DI Record Publish Date: January 20, 2017