NA

Basic Information

• Brand Name: NA
• Primary DI: 06959664900789
• Version / Model: AG-5062-N3024G
• 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: c6e8dad4-3e38-49d1-9082-1f8dbafd469a

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: 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
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46452	Biliary/urinary stone retrieval basket, single-use	A flexible, manual instrument designed to trap/retrieve biliary and/or urinary stones (gallbladder and/or renal/ureteric calculi) from the body during an open surgical and/or endoscopic/laparoscopic procedure [e.g., choledochoscopy, endoscopic retrograde cholangiopancreatography (ERCP)]; it is not intended to fragment/crush. It is typically designed with a long, thin, flexible shank that has an expandable basket of wire (typically metallic) at its distal end in which the stones are caught. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16959664900786	GS1	box	10	In Commercial Distribution
Primary	06959664900789	GS1
Package	26959664900783	GS1	carton	100	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K201509	000