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GORE-TEX Cardiovascular Patch

FDA UDI

Class II (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE-TEX Cardiovascular Patch FDA UDI
Generic Name
Cardiovascular patch, synthetic FDA UDI
Device Name
GORE-TEX CARDIOVASCULAR PATCH 0.6cmX10.0cmX0.4mm FDA UDI
Model / Reference
1800610004 FDA UDI
Description
GORE-TEX CARDIOVASCULAR PATCH 0.6cmX10.0cmX0.4mm FDA UDI

Identifiers

Catalog Number
1800610004 FDA UDI
Primary DI / UDI-DI
00733132600687 FDA UDI
510(k) Number
K912107 FDA UDI
FDA Product Code
DXZ FDA UDI
GMDN Term
Cardiovascular patch, synthetic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3470 FDA UDI
Commercial Distribution
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
Height — .4 Millimeter FDA UDI
Length — 10.0 Centimeter FDA UDI
Width — 0.6 Centimeter FDA UDI

Category: Cardiovascular patch, synthetic

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

Similar devices

Also classified as Cardiovascular patch, synthetic.

Cleared under the same submission

K912107 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 ee3c9ded-3c79-4136-a8b3-fd07f6b677a6 37 fields · synced May 30, 2026