Xact™

FDA UDI

Class III (US FDA UDI)

by Abbott Vascular

Identity

Trade Name: XACT™ FDA UDI
Generic Name: Bare-metal carotid artery stent FDA UDI
Device Name: XACT™ Carotid Stent System 7.0 mm x 30 mm Straight FDA UDI
Model / Reference: 82094-01 FDA UDI
Description: XACT™ Carotid Stent System 7.0 mm x 30 mm Straight FDA UDI

Identifiers

Catalog Number: 82094-01 FDA UDI
Primary DI / UDI-DI: 08717648010309 FDA UDI
FDA Product Code: NIM FDA UDI
GMDN Term: Bare-metal carotid artery 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Bare-metal carotid artery stent

Xact™ by Abbott Vascular — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bare-metal carotid artery stent.

Protege RX — Covidien LP · Class III
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ENROUTE Transcarotid Stent — SILK ROAD MEDICAL, INC. · Class III
Carotid WALLSTENT® — Boston Scientific · Class III
ENROUTE Transcarotid Stent — SILK ROAD MEDICAL, INC. · Class III
ENROUTE Transcarotid Stent — SILK ROAD MEDICAL, INC. · Class III
Roadsaver Carotid Atery Stent — MICROVENTION INC. · Class III
Roadsaver Carotid Atery Stent — MICROVENTION INC. · Class III

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: Abbott Vascular

Sources (1)

FDA UDI 53f7b228-79f5-486e-bda7-9ae5bf0d9398 36 fields · synced May 30, 2026