NA

Basic Information

• Brand Name: NA
• Primary DI: 06959664910740
• Version / Model: AG-5453-10-12-15
• Company Name: Hangzhou AGS MedTech Co., Ltd.
• Labeler DUNS: 542984702
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-09
• Public Version: 1
• Public Version Date: 2022-10-17
• Public Version Status: New
• Public Device Record Key: 122f67ad-ee94-4d57-a89b-d163a3d8afca

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• 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
GCA	Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46715	ERCP catheter, balloon, non-electrical, stone-retrieval	A flexible, tubular, non-electrical device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) from the biliary tract during endoscopic retrograde cholangiopancreatography (ERCP). It is inserted through the working channel of an endoscope, typically beyond the stones, where the balloon is inflated and retracted to push the stones out. It typically has more than one lumen to allow, e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16959664910747	GS1	box	5	In Commercial Distribution
Primary	06959664910740	GS1
Package	26959664910744	GS1	carton	50	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K200173	000