OES TRANSDUODENAL CHOLEDOCHOFIBERSCOPE

GUDID 04953170068751

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible fibreoptic choledochoscope
Primary Device ID04953170068751
NIH Device Record Key8971040b-8b1d-46ab-b6ab-63e1932621e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameOES TRANSDUODENAL CHOLEDOCHOFIBERSCOPE
Version Model NumberOLYMPUS CHF TYPE BP30
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170068751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FBNCholedochoscope and accessories, flexible/rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170068751]

Ethylene Oxide;High-level Disinfectant


[04953170068751]

Ethylene Oxide;High-level Disinfectant


[04953170068751]

Ethylene Oxide;High-level Disinfectant


[04953170068751]

Ethylene Oxide;High-level Disinfectant


[04953170068751]

Ethylene Oxide;High-level Disinfectant


[04953170068751]

Ethylene Oxide;High-level Disinfectant


[04953170068751]

Ethylene Oxide;High-level Disinfectant


[04953170068751]

Ethylene Oxide;High-level Disinfectant


[04953170068751]

Ethylene Oxide;High-level Disinfectant


[04953170068751]

Ethylene Oxide;High-level Disinfectant


[04953170068751]

Ethylene Oxide;High-level Disinfectant


[04953170068751]

Ethylene Oxide;High-level Disinfectant


[04953170068751]

Ethylene Oxide;High-level Disinfectant


[04953170068751]

Ethylene Oxide;High-level Disinfectant


[04953170068751]

Ethylene Oxide;High-level Disinfectant


[04953170068751]

Ethylene Oxide;High-level Disinfectant


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 [OES TRANSDUODENAL CHOLEDOCHOFIBERSCOPE]

04953170339561CHF-BP30 OES CHOLEDOCHOFIBERSCOPE
04953170068751OLYMPUS CHF TYPE BP30

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