AUTOCLAVABLE TRANSDUCER

GUDID 04953170157134

MAJ-1215 AUTOCLAVABLE XDUCER FOR LUS-2

OLYMPUS MEDICAL SYSTEMS CORP.

Ultrasonic lithotripsy system transducer, reusable
Primary Device ID04953170157134
NIH Device Record Key6c8e81f7-ae26-4c32-8432-0a112bb7e9d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUTOCLAVABLE TRANSDUCER
Version Model NumberMAJ-1215
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
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
GS104953170157134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FEOLithotriptor, ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-10-08
Device Publish Date2016-09-21

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