FemCerv

Primary DI
00859500005066
Brand
FemCerv
Company
FEMASYS INC.
Model
FCV-011
Catalog number
03139
Device description
FemCerv, Endocervical Sampler, 11 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
OTC
false
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
20859500005060PrimaryGS10
30859500005067PrimaryGS10
00859500005066Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085950000506020859500005060
3085950000506730859500005067
00859500005066008595000050668595000050660859500005066

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
147590330
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
30859500005050FemCervFEMASYS INC.PCF2022-09-21
30859500005067FemCervFEMASYS INC.PCF2022-09-21
10859500005056FemCervFEMASYS INC.PCF2022-09-21
10859500005063FemCervFEMASYS INC.PCF2022-09-21
00859500005059FemCervFEMASYS INC.PCF2022-09-21
00888937003253Kevor-CuretteCoopersurgical, Inc.PCF2016-09-20
20888937003257Kevor-CuretteCoopersurgical, Inc.PCF2016-09-20