FemCerv

Primary DI
30859500005050
Brand
FemCerv
Company
FEMASYS INC.
Model
FCV-013
Catalog number
03142
Device description
FemCerv, Endocervical Sampler, 13 Fr, 10-pack
Published
2022-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PCFSampler, Endocervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCFSampler, EndocervicalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122658000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122658000FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009Femasys, Inc.2012-12-20PCF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30859500005050PrimaryGS10
00859500005059Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085950000505030859500005050
00859500005059008595000050598595000050590859500005059

GMDN Terms#

Term, Definition table
TermDefinition
Cervical cytology brushA device with bristle-like projections designed to obtain a cervical biopsy of a suspicious area or visible exocervical lesions detected during a vaginal examination for the purpose of obtaining a tissue diagnosis from a woman with intraepithelial disease. It is inserted into the vagina and the head of the brush is firmly rotated over the area of interest until is covered with a bloody-mucoid sample. Some types may also have small bristles on a central protrusion that simultaneously enters the endocervical canal. The sample is secured in a cytology fixation solution or smeared onto a microscope slide for a Papanicolaou test (PAP). This is a single-use device.

Regulatory Flags#

DUNS number
147590330
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859500005288FemSperm Analyzer FSP-500054472026-02-06
00859500005318FemSperm Pack AnalysisFSP-400054442026-02-06
00859500005325FemSperm No AnalysisFSP-401054452026-02-06
00859500005349FemSperm Pack AnalysisFSP-402055492026-02-06
00859500005356FemSperm No AnalysisFSP-403055502026-02-06
20859500005008FemVueFSA-2002026-01-06
30859500005005FemVueFSA-2002026-01-06
20859500005169StopLockSLK-100043912025-05-02
10859500005162StopLockSLK-100043902025-05-02
00859500005165StopLockSLK-100043912025-05-02
30859500005166StopLockSLK-100043922025-05-02
00859500005097FemChec FCD-2502024-09-16
00859500005080FemCathCBC-150041942023-06-06
00859500005127VariLockVL-1001041782024-03-13
00859500005103FemaSeedFDI-2002024-01-22
20859500005107FemaSeedFDI-2002023-11-28
30859500005104FemaSeedFDI-2002023-11-29
10859500005100FemaSeedFDI-2002023-11-28
10859500005018FemaSeedFDI-2002023-11-28
00859500005011FemaSeedFDI-2002023-11-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20859500005053FemCervFEMASYS INC.PCF2022-09-21
20859500005060FemCervFEMASYS INC.PCF2022-09-21
30859500005067FemCervFEMASYS INC.PCF2022-09-21
10859500005056FemCervFEMASYS INC.PCF2022-09-21
10859500005063FemCervFEMASYS INC.PCF2022-09-21
00859500005059FemCervFEMASYS INC.PCF2022-09-21
00859500005066FemCervFEMASYS INC.PCF2022-09-21
00888937003253Kevor-CuretteCoopersurgical, Inc.PCF2016-09-20
20888937003257Kevor-CuretteCoopersurgical, Inc.PCF2016-09-20