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Cervex-Brush

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name
Cervex-Brush FDA UDI
Generic Name
Cervical cytology brush FDA UDI
Device Name
Cervex-Brush® Cervical Cell Sampler For simultaneous cytologic sampling of both the uterine ectocervix and endocervix for such subsequent evaluations as the Papanicolaou Test FDA UDI
Model / Reference
8600 FDA UDI
Description
Cervex-Brush® Cervical Cell Sampler For simultaneous cytologic sampling of both the uterine ectocervix and endocervix for such subsequent evaluations as the Papanicolaou Test FDA UDI

Identifiers

Primary DI / UDI-DI
20888937014390 FDA UDI
510(k) Number
K890848 FDA UDI
FDA Product Code
HHT FDA UDI
GMDN Term
Cervical cytology brush 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cervical cytology brush

Cervex-Brush by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cervical cytology brush.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CooperSurgical, Inc.

Sources (1)

  • FDA UDI adc5e921-40a5-4f77-b6b2-77e755544868 34 fields · synced Jun 9, 2026