Home GUDID 00810142352116 Bioteque America, Inc.
Primary DI 00810142352116
Brand Bioteque America, Inc.
Company Bioteque America, Inc.
Model FS3000
Device description FITTING SET WITH DH/S PESSARY
Published 2025-05-29
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Single use true Product Codes# Code, Name table Code Name HHW Pessary, Vaginal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HHW Pessary, Vaginal Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810142352116 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810142352116 00810142352116 810142352116 0810142352116
GMDN Terms# Term, Definition table Term Definition Pelvic-organ-supporting pessary A device made of rubber or soft plastics designed for insertion into the vagina to hold the uterus, bladder and/or rectum in place and help prevent prolapse (falling or sliding of the organ from its normal position into the pelvic cavity), either as a permanent or temporary treatment; it is not dedicated to bladder-only support. It is available in a variety of shapes (e.g., rings, stems) and sizes; it may be fitted for each woman individually. This is a reusable device after appropriate cleaning.
Regulatory Flags# DUNS number 785179719 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810142350334 Bioteque America, Inc. CUd2 2025-06-02 00810142352307 Bioteque America, Inc. DT-B 2025-05-30 00810142350587 Bioteque America, Inc. CP0 2025-05-29 00810142350594 Bioteque America, Inc. CP1 2025-05-29 00810142350600 Bioteque America, Inc. CP2 2025-05-29 00810142350617 Bioteque America, Inc. CP3 2025-05-29 00810142350624 Bioteque America, Inc. CP4 2025-05-29 00810142350631 Bioteque America, Inc. CP5 2025-05-29 00810142350648 Bioteque America, Inc. CP6 2025-05-29 00810142350655 Bioteque America, Inc. CP7 2025-05-29 00810142350662 Bioteque America, Inc. CPs0 2025-05-29 00810142350679 Bioteque America, Inc. CPs1 2025-05-29 00810142350686 Bioteque America, Inc. CPs2 2025-05-29 00810142350693 Bioteque America, Inc. CPs3 2025-05-29 00810142350709 Bioteque America, Inc. CPs4 2025-05-29 00810142350716 Bioteque America, Inc. CPs5 2025-05-29 00810142350723 Bioteque America, Inc. CPs6 2025-05-29 00810142350730 Bioteque America, Inc. CPs7 2025-05-29 00810142350754 Bioteque America, Inc. DSH1 2025-05-29 00810142350761 Bioteque America, Inc. DSH2 2025-05-29
Other Devices Sharing Product Codes#