Harrell

FDA UDI

Class I (US FDA UDI)

by Conmed Corporation

Identity

Trade Name: Harrell FDA UDI
Generic Name: Flexible endoscopic cytology brush, single-use FDA UDI
Device Name: Harrell Bronchoscope Unsheathed Cytology Brush, No Handle, 4 mm X 110 cm FDA UDI
Model / Reference: 000139 FDA UDI
Description: Harrell Bronchoscope Unsheathed Cytology Brush, No Handle, 4 mm X 110 cm FDA UDI

Identifiers

Catalog Number: 000139 FDA UDI
Primary DI / UDI-DI: 10653405051084 FDA UDI
FDA Product Code: GEE FDA UDI
GMDN Term: Flexible endoscopic cytology brush, single-use 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

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

Sterilization Method

Ethylene Oxide FDA UDI

Category: Flexible endoscopic cytology brush, single-use

Harrell by Conmed Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Flexible endoscopic cytology brush, single-use.

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Disposable Bronchial Cytology Brush — TeleMed Systems · Class II
DISPOSABLE CYTOLOGY BRUSH — Olympus Medical Systems Corporation · Class II
Gyrus ACMI — Gyrus Acmi, Inc. · Class II
Infinity — US Endoscopy · Class II
Hobbs Microbiology Brush — HOBBS MEDICAL, INC. · Class II

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 I	Pending data

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Manufacturer

Manufacturer: Conmed Corporation

Sources (1)

FDA UDI ff80a812-8bfb-407e-8ad2-28ba78a1ff1f 36 fields · synced Jun 1, 2026