SONICBEAT 5 mm, 45 cm, Front-actuated Grip

GUDID 14953170370578

OLYMPUS MEDICAL SYSTEMS CORP.

Soft-tissue ultrasonic surgical system handpiece tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use Soft-tissue ultrasonic surgical system holder/tip, single-use
Primary Device ID14953170370578
NIH Device Record Keyea46a4a7-8b00-4251-af6f-c0176842e884
Commercial Distribution StatusIn Commercial Distribution
Brand NameSONICBEAT 5 mm, 45 cm, Front-actuated Grip
Version Model NumberSB-0545FC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170370571 [Primary]
GS114953170370578 [Package]
Contains: 04953170370571
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFLInstrument, ultrasonic surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-21

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

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