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Isolator Surgical Ablation System

FDA UDI

Class II (US FDA UDI)

by Atricure, Inc.

Identity

Trade Name
Isolator Surgical Ablation System FDA UDI
Generic Name
Cardiac radio-frequency ablation system generator FDA UDI
Device Name
Isolator Synergy Surgical Ablation System, Glidepath Tape, Left Curve FDA UDI
Model / Reference
EML2 FDA UDI
Description
Isolator Synergy Surgical Ablation System, Glidepath Tape, Left Curve FDA UDI

Identifiers

Catalog Number
A000467 FDA UDI
Primary DI / UDI-DI
10840143902222 FDA UDI
FDA Product Code
OCL FDA UDI
GMDN Term
Cardiac radio-frequency ablation system generator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiac radio-frequency ablation system generator

Isolator Surgical Ablation System by Atricure, Inc. — Class II — 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 08dc0894-61b0-417b-ab02-a3b84ab0e145 35 fields · synced May 31, 2026