AG6.510E.4403.000.Z

GUDID 26959664904194

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 ID26959664904194
NIH Device Record Key65386cc5-8057-4cbe-bbdf-86f5d14c7eba
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAG-5104-2300-090-16
Catalog NumberAG6.510E.4403.000.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
GS106959664904190 [Primary]
GS116959664904197 [Package]
Contains: 06959664904190
Package: Box [10 Units]
In Commercial Distribution
GS126959664904194 [Package]
Contains: 16959664904197
Package: Carton [5 Units]
In Commercial Distribution
GS156959664904195 [Package]
Contains: 06959664904190
Package: Box [5 Units]
In Commercial Distribution
GS166959664904192 [Package]
Contains: 56959664904195
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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