Abre™

FDA UDI

Class III (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: Abre™ FDA UDI
Generic Name: Bare-metal peripheral venous stent FDA UDI
Device Name: STENT AB9U20120090 ABRE V01 FDA UDI
Model / Reference: AB9U20120090 FDA UDI
Description: STENT AB9U20120090 ABRE V01 FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169796461 FDA UDI
PMA Number: P200026 FDA UDI
FDA Product Code: QAN FDA UDI
GMDN Term: Bare-metal peripheral venous stent FDA UDI

Classification

Device Class: Class III 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Stent Length — 120.0 Millimeter FDA UDI

Category: Bare-metal peripheral venous stent

Abre™ by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bare-metal peripheral venous stent.

Venovo® — Angiomed GmbH & Co. Medizintechnik KG · Class III
VICI RDS™ Venous Stent System — Veniti Inc · Class III
Venovo® — Angiomed GmbH & Co. Medizintechnik KG · Class III
Duo Hybrid Venous Stent System — Vesper Medical, Inc. · Class III
VICI RDS™ Venous Stent System — Veniti Inc · Class III
Venovo® — Angiomed GmbH & Co. Medizintechnik KG · Class III
Venovo® — Angiomed GmbH & Co. Medizintechnik KG · Class III
Duo Extend Venous Stent System — Vesper Medical, Inc. · Class III

Cleared under the same submission

P200026 also covers:

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 III	Pending data

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Manufacturer

Manufacturer: Medtronic, Inc.

Sources (1)

FDA UDI 7a86d151-42b3-4e58-8b97-411896340af2 37 fields · synced May 30, 2026