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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 T8MM 70CM RS X 100CM FDA UDI
Model / Reference
RRT08070100L FDA UDI
Description
REM RG T8MM 70CM RS X 100CM FDA UDI

Identifiers

Catalog Number
RRT08070100L FDA UDI
Primary DI / UDI-DI
00733132611119 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
Length — 100 Centimeter FDA UDI
Lumen/Inner Diameter — 8 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

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Manufacturer

Manufacturer
W. L. Gore & Associates, Inc

Sources (1)

  • FDA UDI 113cb1c1-4c1e-4b7f-afbb-9d511eeb4392 38 fields · synced May 31, 2026