Barrx

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: Barrx FDA UDI
Generic Name: Endoscope tissue removal cap, single-use FDA UDI
Device Name: RFA Cleaning Cap Small FDA UDI
Model / Reference: CP-001A FDA UDI
Description: RFA Cleaning Cap Small FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521581852 FDA UDI
510(k) Number: K083711 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Endoscope tissue removal cap, single-use 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Endoscope tissue removal cap, single-use

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

Similar devices

Also classified as Endoscope tissue removal cap, single-use.

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FUJIFILM — FUJIFILM Corporation · Class II
FUJIFILM — FUJIFILM Corporation · Class II
FUJIFILM — FUJIFILM Corporation · Class II
Reveal — US Endoscopy · Class II
Reveal — US Endoscopy · Class II
remOVE DC Cutter Set — Ovesco Endoscopy AG · Class II

Cleared under the same submission

K083711 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Covidien LP

Sources (1)

FDA UDI d95b1a8c-c0a4-46d8-b5cf-8e1b4f14a197 35 fields · synced May 31, 2026