GUDID 66959664900392

Hangzhou AGS MedTech Co., Ltd.

Gastrointestinal endoscopic clip, short-term
Primary Device ID66959664900392
NIH Device Record Key6bab4145-566c-4082-aac0-4fe320a3f422
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAG-5011-2316
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 Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS106959664900390 [Primary]
GS116959664900397 [Package]
Contains: 06959664900390
Package: [10 Units]
In Commercial Distribution
GS126959664900394 [Package]
Contains: 16959664900397
Package: [10 Units]
In Commercial Distribution
GS136959664900391 [Package]
Contains: 06959664900390
Package: [2 Units]
In Commercial Distribution
GS146959664900398 [Package]
Contains: 36959664900391
Package: [25 Units]
In Commercial Distribution
GS156959664900395 [Package]
Contains: 06959664900390
Package: [5 Units]
In Commercial Distribution
GS166959664900392 [Package]
Contains: 56959664900395
Package: [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 Number1
Public Version Date2019-05-01
Device Publish Date2019-04-23

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.