Cooper Surgical

Basic Information

• Brand Name: Cooper Surgical
• Primary DI: 04719894433400
• Version / Model: 53404
• Company Name: Bioteque Taiwan Ltd.
• Labeler DUNS: 657769858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-11
• Public Version: 1
• Public Version Date: 2025-03-19
• Public Version Status: New
• Public Device Record Key: a6cf2f8e-e481-4a58-95cd-05b6fdaae0b1

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10695	Bartholin's gland catheter	A short (e.g., 5 cm) plastic tube designed to form a tract from either of the two small reddish glands (Bartholin's glands), one on each side of the vaginal orifice, to the space where the urethra and the vagina open (vaginal vestibulum). It may include a balloon at the tip to ensure retention within the gland. The device is typically used for drainage in the treatment of Bartholin's gland cysts and abscesses. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719894433400	GS1

Premarket Submissions

Submission Number	Supplement Number
K130087	000