Balloon Applicator

GUDID 04953170062865

"6842600 OLA MAJ-864 RADIAL SCOPE BALLOON"

OLYMPUS MEDICAL SYSTEMS CORP.

Ultrasound endoscope balloon, Hevea-latex
Primary Device ID04953170062865
NIH Device Record Key79c51cbd-24ee-4c42-9731-bfa54129c0d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBalloon Applicator
Version Model NumberMAJ-864
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 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
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
GS104953170062865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


[04953170062865]

Ethylene Oxide;High-level Disinfectant


Device Entry Metadata

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

On-Brand Devices [Balloon Applicator]

04953170368547MAJ-564
04953170175626MAJ-1352
04953170065262"MD-688 Balloon applicator for JF-UM20"
04953170062865"6842600 OLA MAJ-864 RADIAL SCOPE BALLOON"
04953170061912MAJ-675
049531700618995792300 OLA MAJ-564 BALLOON APPLICATOR F
04953170055553"MH-526 Balloon applicator for MH-908"

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