GUDID 66959664910940

Hangzhou AGS MedTech Co., Ltd.

Gastrointestinal endoscopic clip, short-term
Primary Device ID66959664910940
NIH Device Record Key25e49ffd-c8a2-4c54-9aff-5861e0781dd6
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAG-5075-241523
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 Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS106959664910948 [Primary]
GS116959664910945 [Package]
Contains: 06959664910948
Package: [10 Units]
In Commercial Distribution
GS126959664910942 [Package]
Contains: 16959664910945
Package: [10 Units]
In Commercial Distribution
GS136959664910949 [Package]
Contains: 06959664910948
Package: [2 Units]
In Commercial Distribution
GS146959664910946 [Package]
Contains: 36959664910949
Package: [25 Units]
In Commercial Distribution
GS156959664910943 [Package]
Contains: 06959664910948
Package: [5 Units]
In Commercial Distribution
GS166959664910940 [Package]
Contains: 56959664910943
Package: [10 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 Date2019-05-01
Device Publish Date2019-04-23

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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