AG6.510E.0497.000.Z

GUDID 26959664900929

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 ID26959664900929
NIH Device Record Key1c32dc61-9921-4e26-a117-7112d43c2a2a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAG-5104-2300-135
Catalog NumberAG6.510E.0497.000.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
GS106959664900925 [Primary]
GS116959664900922 [Package]
Contains: 06959664900925
Package: Box [10 Units]
In Commercial Distribution
GS126959664900929 [Package]
Contains: 16959664900922
Package: Carton [5 Units]
In Commercial Distribution
GS156959664900920 [Package]
Contains: 06959664900925
Package: Box [5 Units]
In Commercial Distribution
GS166959664900927 [Package]
Contains: 56959664900920
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.