GUDID 16959664932688

the Catheter OD is 2.4mm, working length is 2000mm, model of needle is 25, needle extension length is 6 mm, the headend type is tip forming.

Hangzhou AGS MedTech Co., Ltd.

General-purpose endoscopic needle, single-use
Primary Device ID16959664932688
NIH Device Record Key4cdb9987-4555-464b-8fab-75c3787a78d6
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAG-5311-2420-2506
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS106959664932681 [Primary]
GS116959664932688 [Package]
Contains: 06959664932681
Package: Box [10 Units]
In Commercial Distribution
GS126959664932685 [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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