Cooper Surgical

GUDID 04719894433400

Bioteque Taiwan Ltd.

Bartholin's gland catheter
Primary Device ID04719894433400
NIH Device Record Keya6cf2f8e-e481-4a58-95cd-05b6fdaae0b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCooper Surgical
Version Model Number53404
Company DUNS657769858
Company NameBioteque Taiwan Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719894433400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNAInstrument, Manual, Specialized Obstetric-Gynecologic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-19
Device Publish Date2025-03-11

Devices Manufactured by Bioteque Taiwan Ltd.

04719894433400 - Cooper Surgical2025-03-19
04719894433400 - Cooper Surgical2025-03-19
04719894433424 - Bioteque Taiwan Ltd.2025-03-18
04719894430003 - Bioteque Taiwan Ltd.2024-12-16
04719894430010 - Bioteque Taiwan Ltd.2024-12-16
04719894430027 - Bioteque Taiwan Ltd.2024-12-16
04719894430034 - Bioteque Taiwan Ltd.2024-12-16
04719894430041 - Bioteque Taiwan Ltd.2024-12-16
04719894430058 - Bioteque Taiwan Ltd.2024-12-16

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