Bioteque Taiwan Ltd.

Basic Information

• Brand Name: Bioteque Taiwan Ltd.
• Primary DI: 04719894432755
• Version / Model: UIC5F
• Company Name: Bioteque Taiwan Ltd.
• Labeler DUNS: 657769858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-08
• Public Version: 1
• Public Version Date: 2024-04-16
• Public Version Status: New
• Public Device Record Key: 473c0381-3d53-4230-8001-f974c1eef2bc

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18746	Intrauterine imaging medium catheter	A flexible tube designed for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [saline infused sonography (SIS)/ hysterosonography]. It is typically a duel lumen tube, with a non-latex inflatable cuff (balloon), pad or cap near the distal tip intended to seal the cervix, and may include devices dedicated to catheter function (e.g., stylet, syringe). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04719894432786	GS1	box	25	In Commercial Distribution
Primary	04719894432755	GS1

Premarket Submissions

Submission Number	Supplement Number
K102898	000