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Synergy™ Ablation System

FDA UDI

Class I (US FDA UDI)

by Atricure, Inc.

Identity

Trade Name
Synergy™ Ablation System FDA UDI
Generic Name
Cardiac ablation system applicator introducer/sizer FDA UDI
Device Name
Glidepath Tape (1-Unit) FDA UDI
Model / Reference
GPT300 FDA UDI
Description
Glidepath Tape (1-Unit) FDA UDI

Identifiers

Catalog Number
A000423 FDA UDI
Primary DI / UDI-DI
00818354016291 FDA UDI
FDA Product Code
FZX FDA UDI
GMDN Term
Cardiac ablation system applicator introducer/sizer FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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 ablation system applicator introducer/sizer

Synergy™ Ablation System by Atricure, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac ablation system applicator introducer/sizer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atricure, Inc.

Sources (1)

  • FDA UDI dbd134ed-d0d2-4e5f-b0a9-97fef23cb90c 34 fields · synced May 31, 2026