Home GUDID 00810142352369
Bioteque America, Inc.
Primary DI 00810142352369
Brand Bioteque America, Inc.
Company Bioteque America, Inc.
Model BA8200
Device description Preferred Curette Sureflex
Published 2025-05-08
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 HHK Curette, Suction, Endometrial (And Accessories)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810142352369 Package GS1 25 In Commercial Distribution 00810142352338 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 00810142352369 00810142352369 810142352369 0810142352369 00810142352338 00810142352338 810142352338 0810142352338
GMDN Terms# Term, Definition table Term Definition Endometrial biopsy kit A collection of sterile devices designed for the collection of a tissue sample taken from the lining of the uterus (endometrium). It typically includes an aspirating curette, a specimen container and other materials. It is used in the study of endometrial cytology (cells). This is a single-use device.
Regulatory Flags# DUNS number 785179719 Device count 1 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 true Sterilization required before use false 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#