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GORE-TEX Suture

FDA UDI

Class II (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE-TEX Suture FDA UDI
Generic Name
Cardiovascular patch, synthetic FDA UDI
Device Name
GORE-TEX SUTURE CHORDAE TENDIN CV-4 91cm DoubleArm TH-22-1dz FDA UDI
Model / Reference
3200 FDA UDI
Description
GORE-TEX SUTURE CHORDAE TENDIN CV-4 91cm DoubleArm TH-22-1dz FDA UDI

Identifiers

Catalog Number
3200 FDA UDI
Primary DI / UDI-DI
00733132628650 FDA UDI
PMA Number
P820083 FDA UDI
FDA Product Code
GAW FDA UDI
GMDN Term
Cardiovascular patch, synthetic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5010 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 91 Centimeter FDA UDI

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

Cleared under the same submission

P820083 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 c2940e5a-023b-45ec-b1ef-2f30527cab1b 38 fields · synced May 31, 2026