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FemCerv

FDA UDI

Class II (US FDA UDI)

by Femasys Inc.

Identity

Trade Name
FemCerv FDA UDI
Generic Name
Cervical cytology brush FDA UDI
Device Name
FemCerv, Endocervical Sampler, 13 Fr, 1-pack FDA UDI
Model / Reference
FCV-013 FDA UDI
Description
FemCerv, Endocervical Sampler, 13 Fr, 1-pack FDA UDI

Identifiers

Catalog Number
03140 FDA UDI
Primary DI / UDI-DI
10859500005056 FDA UDI
510(k) Number
K122658 FDA UDI
FDA Product Code
PCF FDA UDI
GMDN Term
Cervical cytology brush FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1050 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

Yes

FDA UDI

Category: Cervical cytology brush

FemCerv by Femasys Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cervical cytology brush.

Cleared under the same submission

K122658 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Femasys Inc.

Sources (1)

  • FDA UDI 8b37f625-fb64-4291-8657-a4a1ba827007 35 fields · synced Jun 8, 2026