GUDID 16959664910754

Hangzhou AGS MedTech Co., Ltd.

ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval ERCP catheter, balloon, non-electrical, stone-retrieval

• Primary Device ID: 16959664910754
• NIH Device Record Key: 6a417f86-13ab-40d6-8d90-202210d7c7a5
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: AG-5453-13-15-18
• Company DUNS: 542984702
• Company Name: Hangzhou AGS MedTech Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06959664910757 [Primary]
GS1	16959664910754 [Package]; Contains: 06959664910757; Package: box [5 Units]; In Commercial Distribution
GS1	26959664910751 [Package]; Package: carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200173

FDA Product Code

• GCA: Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-17
• Device Publish Date: 2022-10-09

Devices Manufactured by Hangzhou AGS MedTech Co., Ltd.

• 16959664911959 - NA: 2023-04-10
• 16959664911966 - NA: 2023-04-10
• 16959664913496 - NA: 2023-04-10
• 16959664934279 - NA: 2023-04-10
• 16959664934316 - NA: 2023-04-10
• 16959664902087 - NA: 2022-10-20
• 16959664902100 - NA: 2022-10-20
• 16959664902162 - NA: 2022-10-20