4K CAMERA HEAD

GUDID 04953170375552

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscope video camera
Primary Device ID04953170375552
NIH Device Record Keyd8ee3314-d705-4ffe-8da5-0859be95ad1e
Commercial Distribution StatusIn Commercial Distribution
Brand Name4K CAMERA HEAD
Version Model NumberOLYMPUS CH-S400-XZ-EA
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 Batchfalse
Serial Numbertrue
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
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170375552 [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

[04953170375552]

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


[04953170375552]

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


[04953170375552]

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


[04953170375552]

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


[04953170375552]

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


[04953170375552]

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


[04953170375552]

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


[04953170375552]

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


[04953170375552]

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


[04953170375552]

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


[04953170375552]

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


[04953170375552]

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


[04953170375552]

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


[04953170375552]

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


[04953170375552]

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


[04953170375552]

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


[04953170375552]

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


[04953170375552]

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


[04953170375552]

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


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-10-08
Device Publish Date2017-12-05

On-Brand Devices [4K CAMERA HEAD]

04953170375552OLYMPUS CH-S400-XZ-EA
04953170374609OLYMPUS CH-S400-XZ-EB

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