← Back to catalogue

GORE-TEX Vascular Graft

FDA UDI

Class II (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE-TEX Vascular Graft FDA UDI
Generic Name
Synthetic vascular graft FDA UDI
Device Name
REM RG 4-7MM 80CM RS OS X 90CM FDA UDI
Model / Reference
RR47080090NL FDA UDI
Description
REM RG 4-7MM 80CM RS OS X 90CM FDA UDI

Identifiers

Catalog Number
RR47080090NL FDA UDI
Primary DI / UDI-DI
00733132610860 FDA UDI
510(k) Number
K880167 FDA UDI
FDA Product Code
DSY FDA UDI
GMDN Term
Synthetic vascular graft FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3450 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 7 Millimeter FDA UDI
Length — 90 Centimeter FDA UDI
Lumen/Inner Diameter — 4 Millimeter FDA UDI

GORE-TEX Vascular Graft by W. L. Gore & Associates, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K880167 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
W. L. Gore & Associates, Inc

Sources (1)

  • FDA UDI 672b10fb-b46e-43c0-b4cd-93797f9421ef 38 fields · synced May 30, 2026