IN12-256231802

GUDID 26932503533250

POM inner tuber,Needle Length 6mm,with metal cap 25G*6*2.3*180,Shroat stucture

Micro-Tech (Nanjing) Co., Ltd.

Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle Submucosal injection needle
Primary Device ID26932503533250
NIH Device Record Keyaaf2cb3d-0d17-4efd-98f9-203a6ddd6392
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberIN12-256231802
Catalog NumberIN12-256231802
Company DUNS530269083
Company NameMicro-Tech (Nanjing) 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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106932503533256 [Primary]
GS116932503533253 [Package]
Contains: 06932503533256
Package: box [10 Units]
In Commercial Distribution
GS126932503533250 [Package]
Contains: 16932503533253
Package: case [10 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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-03-10

Devices Manufactured by Micro-Tech (Nanjing) Co., Ltd.

16932503563700 - MT2024-02-19 Minimum Required Working Channel :4.2mm,Minimum Working Channel Width:2.0mm
16932503563762 - MT2024-02-19 Minimum Required Working Channel :3.7mm,Minimum Working Channel Width:1.2mm
16932503513705 - MT2023-12-08 TPU, Double pigtails,7Fr,5cm
16932503513712 - MT2023-12-08 TPU, Double pigtails,7Fr,7cm
16932503513729 - MT2023-12-08 TPU, Double pigtails,7Fr,10cm
16932503513736 - MT2023-12-08 TPU, Double pigtails,7Fr,12cm
16932503513743 - MT2023-12-08 TPU, Double pigtails,7Fr,15cm
16932503513750 - MT2023-12-08 TPU, Double pigtails,8.5Fr,3cm

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