← Back to catalogue

AtriCure Isolator Synergy EnCompass Clamp and Guide System

FDA UDI

Class II (US FDA UDI)

by Atricure, Inc.

Identity

Trade Name
AtriCure Isolator Synergy EnCompass Clamp and Guide System FDA UDI
Generic Name
Cardiac radio-frequency ablation system generator FDA UDI
Device Name
Surgical Ablation System Open, Long Jaw with Glidepath Magnetic Guide FDA UDI
Model / Reference
OLH FDA UDI
Description
Surgical Ablation System Open, Long Jaw with Glidepath Magnetic Guide FDA UDI

Identifiers

Catalog Number
A001143 FDA UDI
Primary DI / UDI-DI
10840143904110 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

AtriCure Isolator Synergy EnCompass Clamp and Guide 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Atricure, Inc.

Sources (1)

  • FDA UDI 7638a44d-f9f7-400a-86db-4effaf575673 36 fields · synced May 30, 2026