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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
Ultra Long RFA Focal Catheter,80 Applications FDA UDI
Model / Reference
90-9200 FDA UDI
Description
Ultra Long RFA Focal Catheter,80 Applications FDA UDI

Identifiers

Primary DI / UDI-DI
10884521189379 FDA UDI
510(k) Number
K120431 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

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

Dimensions & Sizes

Size
Width — 13 Millimeter FDA UDI
Length — 40 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.

Cleared under the same submission

K120431 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 3c0e8625-693f-4c0e-9c17-ff0e2cdf8ec0 36 fields · synced May 30, 2026