Flixene

FDA UDI

Class II (US FDA UDI)

by Atrium Medical Corp.

Identity

Trade Name: FLIXENE FDA UDI
Generic Name: Synthetic vascular graft FDA UDI
Device Name: 6MM X 10CM, FLIXENE GRAFT FDA UDI
Model / Reference: 25053 FDA UDI
Description: 6MM X 10CM, FLIXENE GRAFT FDA UDI

Identifiers

Primary DI / UDI-DI: 00650862250534 FDA UDI
510(k) Number: K060124 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: 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

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

FDA UDI

Category: Synthetic vascular graft

Flixene by Atrium Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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COOK — William Cook Europe ApS · Class III
Gelweave™ — VASCUTEK LTD · Class II
Zenith — WILLIAM A. COOK AUSTRALIA PTY. LTD. · Class III
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: Atrium Medical Corp.

Sources (1)

FDA UDI f4916b81-7437-4150-ba70-ca90f6c6fd09 35 fields · synced Jun 1, 2026