GORE PROPATEN Vascular Graft Pediatric Shunt

FDA UDI

Class II (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name: GORE PROPATEN Vascular Graft Pediatric Shunt FDA UDI
Generic Name: Synthetic vascular graft FDA UDI
Device Name: PROPATEN VASC GRAFT TW PEDS 3mmX10cm Ped Shunt Heparin FDA UDI
Model / Reference: HPT030010A FDA UDI
Description: PROPATEN VASC GRAFT TW PEDS 3mmX10cm Ped Shunt Heparin FDA UDI

Identifiers

Catalog Number: HPT030010A FDA UDI
Primary DI / UDI-DI: 00733132606214 FDA UDI
FDA Product Code: DSY FDA UDI
DYF FDA UDI
GMDN Term: Synthetic vascular graft FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3450 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

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 — 10 Centimeter FDA UDI

Category: Synthetic vascular graft

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

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Also classified as Synthetic vascular graft.

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Zenith — WILLIAM A. COOK AUSTRALIA PTY. LTD. · Class III
ADVANTA SLIDER GDS — Atrium Medical Corp. · Class II
Gelweave Vascular Prostheses — VASCUTEK LTD · Class II
IMPRA® ePTFE Vascular Grafts — Bard Peripheral Vascular · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: W. L. Gore & Associates, Inc

Sources (1)

FDA UDI e175a704-e066-4916-bf31-2156aac96d9d 36 fields · synced May 31, 2026