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 9.0 mm x 40 mm Tapered FDA UDI
Model / Reference: 82086-01 FDA UDI
Description: XACT™ Carotid Stent System 9.0 mm x 40 mm Tapered FDA UDI

Identifiers

Catalog Number: 82086-01 FDA UDI
Primary DI / UDI-DI: 08717648010224 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

A comprehensive medical device directory featuring the XACT Carotid Stent System 9.0 mm x 40 mm Tapered, a non-bioabsorbable tubular device designed for implantation in patients with atherosclerotic disease to maintain arterial patency and improve luminal diameter.

Similar devices

Also classified as Bare-metal carotid artery stent.

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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 419307a8-5ac7-46f5-9953-ef93bd06efd0 36 fields · synced Jul 27, 2026