GUDID 66959664900446

Hangzhou AGS MedTech Co., Ltd.

Gastrointestinal endoscopic clip, short-term
Primary Device ID66959664900446
NIH Device Record Key077f1403-98f1-461e-899a-1d22812f42b5
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAG-5012-2316
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
GS106959664900444 [Primary]
GS116959664900441 [Package]
Contains: 06959664900444
Package: [10 Units]
In Commercial Distribution
GS126959664900448 [Package]
Contains: 16959664900441
Package: [10 Units]
In Commercial Distribution
GS136959664900445 [Package]
Contains: 06959664900444
Package: [2 Units]
In Commercial Distribution
GS146959664900442 [Package]
Contains: 36959664900445
Package: [25 Units]
In Commercial Distribution
GS156959664900449 [Package]
Contains: 06959664900444
Package: [5 Units]
In Commercial Distribution
GS166959664900446 [Package]
Contains: 56959664900449
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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