GUDID 16959664915148

Hangzhou AGS MedTech Co., Ltd.

Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term
Primary Device ID16959664915148
NIH Device Record Key56ade23e-830d-4aa0-a04f-3cd46bbe9c7b
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAG-51041-2300-135-16
Company DUNS542984702
Company NameHangzhou AGS MedTech Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106959664915141 [Primary]
GS116959664915148 [Package]
Contains: 06959664915141
Package: box [10 Units]
In Commercial Distribution
GS126959664915145 [Package]
Package: carton [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PKLHemostatic Metal Clip For The Gi Tract

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-17
Device Publish Date2022-10-09

Devices Manufactured by Hangzhou AGS MedTech Co., Ltd.

16959664911959 - NA2023-04-10
16959664911966 - NA2023-04-10
16959664913496 - NA2023-04-10
16959664934279 - NA2023-04-10
16959664934316 - NA2023-04-10
16959664902087 - NA2022-10-20
16959664902100 - NA2022-10-20
16959664902162 - NA2022-10-20

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