GUDID 66959664911220

Hangzhou AGS MedTech Co., Ltd.

Gastrointestinal endoscopic clip, short-term
Primary Device ID66959664911220
NIH Device Record Keyd775488e-a83b-485f-818a-cdb4a58ce97f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAG-55344-2300-090-16S
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 TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS106959664911228 [Primary]
GS116959664911225 [Package]
Contains: 06959664911228
Package: [10 Units]
In Commercial Distribution
GS126959664911222 [Package]
Contains: 16959664911225
Package: [5 Units]
In Commercial Distribution
GS136959664911229 [Package]
Contains: 06959664911228
Package: [2 Units]
In Commercial Distribution
GS146959664911226 [Package]
Contains: 36959664911229
Package: [25 Units]
In Commercial Distribution
GS156959664911223 [Package]
Contains: 06959664911228
Package: [5 Units]
In Commercial Distribution
GS166959664911220 [Package]
Contains: 56959664911223
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 Date2018-08-06
Device Publish Date2018-07-05

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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