Single Use Injector

GUDID 14953170259934

Single Use Injector

OLYMPUS MEDICAL SYSTEMS CORP.

General-purpose endoscopic needle, single-use
Primary Device ID14953170259934
NIH Device Record Keyab181ada-a4a0-48ab-81c1-18b18ac4a993
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle Use Injector
Version Model NumberNM-400U-0425
Company DUNS711789789
Company NameOLYMPUS MEDICAL SYSTEMS CORP.
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 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+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170259937 [Primary]
GS114953170259934 [Package]
Contains: 04953170259937
Package: [5 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 Date2016-09-21

On-Brand Devices [Single Use Injector]

14953170382397NM-400Y-0423
14953170382380NM-401L-0625
14953170382373NM-401L-0623
14953170382366NM-401L-0525
14953170382359NM-401L-0523
14953170382342NM-401L-0425
14953170382335NM-401L-0423
14953170382328NM-400U-0625
14953170382311NM-400U-0623
14953170382304NM-400U-0525
14953170382298NM-400U-0523
14953170382281NM-400U-0425
14953170382274NM-400U-0423
14953170382267NM-400U-0323
14953170382250NM-400L-0625
14953170382243NM-400L-0623
14953170382236NM-400L-0621
14953170382229NM-400L-0525
14953170382212NM-400L-0523
14953170382205NM-400L-0425
14953170382199NM-400L-0423
14953170382182NM-400L-0421
14953170260114NM-401L-0625
14953170260091Single Use Injector
14953170260077Single Use Injector
14953170260053NM-401L-0623
14953170260039NM-401L-0523
14953170260015Single Use Injector
14953170259996Single Use Injector
14953170259972Single Use Injector
14953170259958Single Use Injector
14953170259934Single Use Injector
14953170259910NM-400U-0623
14953170259897Single Use Injector
14953170259873NM-400U-0423
14953170259859NM-400U-0323
14953170259835Single Use Injector
14953170259811Single Use Injector
14953170259798NM-400L-0425
14953170259774Single Use Injector
14953170259750NM-400L-0523
14953170259736NM-400L-0423
14953170259712Single Use Injector
14953170259699Single Use Injector
14953170454032NM-401L-0423
14953170454025NM-400U-0425
14953170454018NM-400L-0423

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.