GUDID 16959664932572

the Catheter OD is 2.4mm, working length is 1600mm, model of needle is 24, needle extension length is 6 mm, the headend type is metal cap

Hangzhou AGS MedTech Co., Ltd.

General-purpose endoscopic needle, single-use
Primary Device ID16959664932572
NIH Device Record Keyd4c0f4c2-cd96-4292-a797-a88aadbd0cb7
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAG-5311-2416-2406M
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
GS106959664932575 [Primary]
GS116959664932572 [Package]
Contains: 06959664932575
Package: Box [10 Units]
In Commercial Distribution
GS126959664932579 [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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