GUDID 66959664903331

Hangzhou AGS MedTech Co., Ltd.

Gastrointestinal endoscopic clip, short-term
Primary Device ID66959664903331
NIH Device Record Key577321b7-af4a-4afe-9f25-eaa9dfbd7e8c
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAG-5033-2323
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
GS106959664903339 [Primary]
GS116959664903336 [Package]
Contains: 06959664903339
Package: [10 Units]
In Commercial Distribution
GS126959664903333 [Package]
Contains: 16959664903336
Package: [10 Units]
In Commercial Distribution
GS136959664903330 [Package]
Contains: 06959664903339
Package: [2 Units]
In Commercial Distribution
GS146959664903337 [Package]
Contains: 36959664903330
Package: [25 Units]
In Commercial Distribution
GS156959664903334 [Package]
Contains: 06959664903339
Package: [5 Units]
In Commercial Distribution
GS166959664903331 [Package]
Contains: 56959664903334
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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