GUDID 66959664903300

Hangzhou AGS MedTech Co., Ltd.

Gastrointestinal endoscopic clip, short-term
Primary Device ID66959664903300
NIH Device Record Keyfd69a512-52f9-4af9-a513-50291b03e0d0
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAG-5032-1816
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
GS106959664903308 [Primary]
GS116959664903305 [Package]
Contains: 06959664903308
Package: [10 Units]
In Commercial Distribution
GS126959664903302 [Package]
Contains: 16959664903305
Package: [10 Units]
In Commercial Distribution
GS136959664903309 [Package]
Contains: 06959664903308
Package: [2 Units]
In Commercial Distribution
GS146959664903306 [Package]
Contains: 36959664903309
Package: [25 Units]
In Commercial Distribution
GS156959664903303 [Package]
Contains: 06959664903308
Package: [5 Units]
In Commercial Distribution
GS166959664903300 [Package]
Contains: 56959664903303
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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