AG6.510E.0403.000.Z

GUDID 26959664903104

The Max OD. of insertion part is 2.6mm. Opening Span is 11mm. Working length 2300mm with plastic covered. Rotatable. Open and close repeatedly.

Hangzhou AGS MedTech Co., Ltd.

Gastrointestinal endoscopic clip, short-term
Primary Device ID26959664903104
NIH Device Record Keyee9309e6-651b-4829-96ba-0976c61d4773
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAG-5104-2300-090
Catalog NumberAG6.510E.0403.000.Z
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS106959664903100 [Primary]
GS116959664903107 [Package]
Contains: 06959664903100
Package: Box [10 Units]
In Commercial Distribution
GS126959664903104 [Package]
Contains: 16959664903107
Package: Carton [5 Units]
In Commercial Distribution
GS156959664903105 [Package]
Contains: 06959664903100
Package: Box [5 Units]
In Commercial Distribution
GS166959664903102 [Package]
Contains: 56959664903105
Package: Carton [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 Number2
Public Version Date2018-07-06
Device Publish Date2018-05-28

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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