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Barrx

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
Barrx FDA UDI
Generic Name
Gastrointestinal radio-frequency ablation system catheter FDA UDI
Device Name
Barrx SB RFA Endoscopic Catheter FDA UDI
Model / Reference
TTS-2100 FDA UDI
Description
Barrx SB RFA Endoscopic Catheter FDA UDI

Identifiers

Primary DI / UDI-DI
10884521663503 FDA UDI
510(k) Number
K173559 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Gastrointestinal radio-frequency ablation system catheter 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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 10.75 Millimeter FDA UDI
Width — 7.5 Millimeter FDA UDI

Category: Gastrointestinal radio-frequency ablation system catheter

Barrx by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal radio-frequency ablation system catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI f50735ec-9120-4849-a156-c323b6074cda 36 fields · synced May 29, 2026