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Ablation Sensing Unit

FDA UDI

Class III (US FDA UDI)

by Atricure, Inc.

Identity

Trade Name
Ablation Sensing Unit FDA UDI
Generic Name
Cardiac radio-frequency ablation system generator FDA UDI
Device Name
ASU Footswitch FDA UDI
Model / Reference
FSW2 FDA UDI
Description
ASU Footswitch FDA UDI

Identifiers

Catalog Number
A000049 FDA UDI
Primary DI / UDI-DI
10840143904028 FDA UDI
FDA Product Code
OCM FDA UDI
GMDN Term
Cardiac radio-frequency ablation system generator FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiac radio-frequency ablation system generator

Ablation Sensing Unit by Atricure, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac radio-frequency ablation system generator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atricure, Inc.

Sources (1)

  • FDA UDI f71503f1-316c-401b-981c-5c83452ede94 36 fields · synced May 30, 2026