GUDID 66959664910841

The Max OD. of insertion part is 2.6mm. Opening Span is 16mm. Working length 2300mm with plastic covered. Rotatable. Open and close repeatedly.

Hangzhou AGS MedTech Co., Ltd.

Gastrointestinal endoscopic clip, short-term

• Primary Device ID: 66959664910841
• NIH Device Record Key: 4455d393-1098-4e51-8282-1c010444b7ae
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: AG-5022-2323
• Company DUNS: 542984702
• Company Name: Hangzhou AGS MedTech Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06959664910849 [Primary]
GS1	16959664910846 [Package]; Contains: 06959664910849; Package: [10 Units]; In Commercial Distribution
GS1	26959664910843 [Package]; Contains: 16959664910846; Package: [10 Units]; In Commercial Distribution
GS1	36959664910840 [Package]; Contains: 06959664910849; Package: [2 Units]; In Commercial Distribution
GS1	46959664910847 [Package]; Contains: 36959664910840; Package: [25 Units]; In Commercial Distribution
GS1	56959664910844 [Package]; Contains: 06959664910849; Package: [5 Units]; In Commercial Distribution
GS1	66959664910841 [Package]; Contains: 56959664910844; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172727

FDA Product Code

• PKL: Hemostatic Metal Clip For The Gi Tract

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: 2019-04-30
• Device Publish Date: 2019-04-22

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