GUDID 16959664910716

Hangzhou AGS MedTech Co., Ltd.

ERCP catheter, balloon, non-electrical, stone-retrieval
Primary Device ID16959664910716
NIH Device Record Key133d00b2-5435-4419-96b5-5c02b79ba2d6
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAG-5451-13-15-18
Company DUNS542984702
Company NameHangzhou AGS MedTech Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Identifiers

Device Issuing AgencyDevice ID
GS106959664910719 [Primary]
GS116959664910716 [Package]
Contains: 06959664910719
Package: box [5 Units]
In Commercial Distribution
GS126959664910713 [Package]
Package: carton [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-17
Device Publish Date2022-10-09

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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