WATER-RESISTANT CAP

GUDID 04953170365478

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic device sterilization/disinfection tubing set
Primary Device ID04953170365478
NIH Device Record Key8f777e1f-c26f-4662-8ed1-a8e1e059b030
Commercial Distribution StatusIn Commercial Distribution
Brand NameWATER-RESISTANT CAP
Version Model NumberMAJ-962
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
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
GS104953170365478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDAEnteroscope and accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


[04953170365478]

High-level Disinfectant;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-08
Device Publish Date2016-09-21

On-Brand Devices [WATER-RESISTANT CAP]

04953170368455MAJ-1174
04953170365478MAJ-962
04953170305764MAJ-1899 ScopeGuide Water-resistent Cap
04953170154492MAJ-1214 A/C WTR RES CAP LTF-160/Q180AC
04953170153891MAJ-1195 Water resistant cap for AT8 EUS
04953170143670MAJ-1174
04953170137518MAJ-1057
04953170062971MAJ-896
04953170437748MH-553

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