Histobrush® Cytology Brush

FDA UDI

Class II (US FDA UDI)

by Puritan Medical Products Company Llc

Identity

Trade Name: Histobrush® Cytology Brush FDA UDI
Generic Name: Cytology scraper, single-use FDA UDI
Device Name: Histobrush 8” Soft Tapered Nylon Bristles Cytology Brush w/Polystyrene Handle - 2188 FDA UDI
Model / Reference: 2188 FDA UDI
Description: Histobrush 8” Soft Tapered Nylon Bristles Cytology Brush w/Polystyrene Handle - 2188 FDA UDI

Identifiers

Catalog Number: 2188 FDA UDI
Primary DI / UDI-DI: 30609576250089 FDA UDI
510(k) Number: K111681 FDA UDI
FDA Product Code: HHT FDA UDI
GMDN Term: Cytology scraper, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.4530 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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: Cytology scraper, single-use

Histobrush® Cytology Brush by Puritan Medical Products Company Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Cytology scraper, single-use.

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Rovers® EndoCervex-Brush®-S — Rovers Medical Devices B.V. · Class II

Cleared under the same submission

K111681 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: Puritan Medical Products Company Llc

Sources (1)

FDA UDI fc6b8523-5e6c-4180-8df0-74b16cde9fcf 35 fields · synced Jun 8, 2026