Ultrasonic Surgical System SonoSurg

GUDID 14953170211765

OLYMPUS MEDICAL SYSTEMS CORP.

Surgical power tool hand-switch
Primary Device ID14953170211765
NIH Device Record Key9c0803a6-9611-4273-b1d9-1c0374ec0446
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltrasonic Surgical System SonoSurg
Version Model NumberSonoSurg US Hand Switch MAJ-677
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
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
GS104953170211768 [Primary]
GS114953170211765 [Package]
Contains: 04953170211768
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


[14953170211765]

Moist Heat or Steam Sterilization


Device Entry Metadata

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

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

04953170452475 - EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE2024-10-14
04953170464935 - THUNDERBEAT 5 mm, 45 cm, Pistol Grip2024-09-17
04953170464973 - THUNDERBEAT 5 mm, 35 cm, Inline Grip2024-09-17
04953170464980 - THUNDERBEAT 5 mm, 45 cm, Inline Grip2024-09-17
14953170464994 - SONICBEAT 5 mm, 10 cm, Inline Grip2024-09-17
14953170465021 - SONICBEAT 5 mm, 35 cm, Pistol Grip2024-09-17
14953170465045 - SONICBEAT 5 mm, 45 cm, Pistol Grip2024-09-17
14953170409971 - Single Use Aspiration Needle NA-U401SX2024-07-11

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