Injection tube

GUDID 04953170071324

OLYMPUS MEDICAL SYSTEMS CORP.

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Primary Device ID04953170071324
NIH Device Record Keye27983ff-2c94-4f26-a247-00358952a526
Commercial Distribution StatusIn Commercial Distribution
Brand NameInjection tube
Version Model NumberMH-946
Company DUNS711789789
Company NameOLYMPUS MEDICAL SYSTEMS CORP.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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
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
GS104953170071324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FETEndoscopic video imaging system/component, gastroenterology-urology

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170071324]

High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170071324]

High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170071324]

High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170071324]

High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170071324]

High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170071324]

High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170071324]

High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170071324]

High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170071324]

High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170071324]

High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170071324]

High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170071324]

High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170071324]

High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170071324]

High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170071324]

High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170071324]

High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170071324]

High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-08
Device Publish Date2016-09-21

On-Brand Devices [Injection tube]

04953170154324MAJ-1232, INJECTION TUBE FOR P EF-V
04953170071324MH-946
04953170437731MH-946

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