Clear-Jet Injection Catheter

GUDID 18809327352422

23G-4mm/ 0.08T/ 2,300mm/ Non-head

FINEMEDIX CO.,LTD.

General-purpose endoscopic needle, single-use
Primary Device ID18809327352422
NIH Device Record Key8439a18b-2441-424c-94ef-718586e1ee6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameClear-Jet Injection Catheter
Version Model NumberFM-EI0002(I2)(2300)(0.08T)
Company DUNS688256864
Company NameFINEMEDIX 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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82537418388
Emailfinemedix@finemedix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108809327352425 [Primary]
GS118809327352422 [Package]
Contains: 08809327352425
Package: Box [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-22
Device Publish Date2019-04-12

On-Brand Devices [Clear-Jet Injection Catheter ]

0880932735243223G-6mm/ 0.1T/ 2,300mm
1880932735242223G-4mm/ 0.08T/ 2,300mm/ Non-head
1880932735241523G-4mm/ 0.1T/ 1,800mm
1880932735240823G-4mm/ 0.05T/ 1,800mm
1880932735239223G-4mm/ 0.1T/ 2,300mm
1880932735238523G-4mm/ 0.05T/ 2,300mm
0880932735108423G-6mm/ 0.05T/ 2,300mm
1880932735067123G-4mm/ 0.05T/ 2,300mm/ Non-head
1880932735066423G-4mm/ 0.1T/ 2,300mm/ Non-head

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