AG6.510E.4497.000.Z

GUDID 66959664902983

The Max OD. of insertion part is 2.6mm. Opening Span is 16mm. Working length 2300mm with plastic covered. Rotatable. Open and close repeatedly.

Hangzhou AGS MedTech Co., Ltd.

Gastrointestinal endoscopic clip, short-term
Primary Device ID66959664902983
NIH Device Record Key083761bf-a7b3-498c-87cd-78d597cf7edb
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAG-5104-2300-135-16
Catalog NumberAG6.510E.4497.000.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
GS106959664902981 [Primary]
GS116959664902988 [Package]
Contains: 06959664902981
Package: Box [10 Units]
In Commercial Distribution
GS126959664902985 [Package]
Contains: 16959664902988
Package: Carton [5 Units]
In Commercial Distribution
GS156959664902986 [Package]
Contains: 06959664902981
Package: Box [5 Units]
In Commercial Distribution
GS166959664902983 [Package]
Contains: 56959664902986
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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