EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE

GUDID 04953170237423

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video enteroscope
Primary Device ID04953170237423
NIH Device Record Keyeaf2131f-ae75-478a-bf6a-dcd1bb170bf5
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVIS EXERA II SMALL INTESTINAL VIDEOSCOPE
Version Model NumberOLYMPUS SIF TYPE Q180
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170237423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDAEnteroscope and accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170237423]

High-level Disinfectant;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-21
Device Publish Date2016-09-21

On-Brand Devices [EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE]

04953170339943"SIF-Q180 SMALL INTESTINAL VIDEOSCOPE WIT"
04953170339936OLYMPUS SIF TYPE Q180
04953170242526OLYMPUS SIF TYPE Q180
04953170237423OLYMPUS SIF TYPE Q180

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