GUDID 16959664932336

the Catheter OD is 2.4mm, working length is 2000mm, model of needle is 23, needle extension length is 4 mm, the headend type is metal cap

Hangzhou AGS MedTech Co., Ltd.

General-purpose endoscopic needle, single-use
Primary Device ID16959664932336
NIH Device Record Keyced489e9-dca9-463a-a561-f78da6550666
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAG-5311-2420-2304M
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS106959664932339 [Primary]
GS116959664932336 [Package]
Contains: 06959664932339
Package: Box [10 Units]
In Commercial Distribution
GS126959664932333 [Package]
Package: Carton [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FBKEndoscopic Injection Needle, Gastroenterology-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-14
Device Publish Date2021-12-06

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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