← Back to catalogue

GORE-TEX Vascular Graft Pediatric Shunt

FDA UDI

Class II (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE-TEX Vascular Graft Pediatric Shunt FDA UDI
Generic Name
Synthetic vascular graft FDA UDI
Device Name
STR T3MM X 15CM SILK STRETCH FDA UDI
Model / Reference
ST03015A FDA UDI
Description
STR T3MM X 15CM SILK STRETCH FDA UDI

Identifiers

Catalog Number
ST03015A FDA UDI
Primary DI / UDI-DI
00733132612529 FDA UDI
510(k) Number
K013250 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 — 3 Millimeter FDA UDI
Length — 15 Centimeter FDA UDI

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

Cleared under the same submission

K013250 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 e21d4bf3-2ce2-4feb-b2b8-3affb05f2062 38 fields · synced Jun 1, 2026