Home GUDID 00859500005059 FemCerv
Primary DI 00859500005059
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
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name PCF Sampler, Endocervical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PCF Sampler, Endocervical Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20859500005053 Primary GS1 0 30859500005050 Primary GS1 0 00859500005059 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20859500005053 20859500005053 30859500005050 30859500005050 00859500005059 00859500005059 859500005059 0859500005059
GMDN Terms# Term, Definition table Term Definition Cervical cytology brush A 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 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B382SD9150991000 Surgical Direct Surgical Direct, Inc. PCF 2026-07-28 B382SD91553010100 Surgical Direct Surgical Direct, Inc. PCF 2026-07-28 B382SD91553010110 Surgical Direct Surgical Direct, Inc. PCF 2026-07-28 B382SD9155301040 Surgical Direct Surgical Direct, Inc. PCF 2026-07-28 B382SD9155301050 Surgical Direct Surgical Direct, Inc. PCF 2026-07-28 B382SD9155301060 Surgical Direct Surgical Direct, Inc. PCF 2026-07-28 B382SD9155301080 Surgical Direct Surgical Direct, Inc. PCF 2026-07-28 B382SD915580100 Surgical Direct Surgical Direct, Inc. PCF 2026-07-28 20859500005053 FemCerv FEMASYS INC. PCF 2022-09-21 20859500005060 FemCerv FEMASYS INC. PCF 2022-09-21 30859500005050 FemCerv FEMASYS INC. PCF 2022-09-21 30859500005067 FemCerv FEMASYS INC. PCF 2022-09-21 10859500005056 FemCerv FEMASYS INC. PCF 2022-09-21 10859500005063 FemCerv FEMASYS INC. PCF 2022-09-21 00859500005066 FemCerv FEMASYS INC. PCF 2022-09-21 00888937003253 Kevor-Curette Coopersurgical, Inc. PCF 2016-09-20 20888937003257 Kevor-Curette Coopersurgical, Inc. PCF 2016-09-20