Home GUDID 30859500005050 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 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 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 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 Lot or batch true Manufacturing date on label true Expiration date on label true 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 30859500005067 FemCerv FEMASYS INC. PCF 2022-09-21 10859500005056 FemCerv FEMASYS INC. PCF 2022-09-21 10859500005063 FemCerv FEMASYS INC. PCF 2022-09-21 00859500005059 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