GUDID 66959664909562

Hangzhou AGS MedTech Co., Ltd.

Gastrointestinal endoscopic clip, short-term
Primary Device ID66959664909562
NIH Device Record Key019dd1e9-6166-4654-9e23-70593f06f5cf
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAG-5332-241523
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 TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106959664909560 [Primary]
GS116959664909567 [Package]
Contains: 06959664909560
Package: [10 Units]
In Commercial Distribution
GS126959664909564 [Package]
Contains: 16959664909567
Package: [10 Units]
In Commercial Distribution
GS136959664909561 [Package]
Contains: 06959664909560
Package: [2 Units]
In Commercial Distribution
GS146959664909568 [Package]
Contains: 36959664909561
Package: [25 Units]
In Commercial Distribution
GS156959664909565 [Package]
Contains: 06959664909560
Package: [5 Units]
In Commercial Distribution
GS166959664909562 [Package]
Contains: 56959664909565
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 Date2019-05-02
Device Publish Date2019-04-24

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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