SonoSurg GE Sheath Attachment

GUDID 14953170182997

OLYMPUS MEDICAL SYSTEMS CORP.

Soft-tissue ultrasonic surgical system
Primary Device ID14953170182997
NIH Device Record Key1b6272d8-c1ff-4f05-9380-c5c9a68247bc
Commercial Distribution Discontinuation2018-03-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSonoSurg GE Sheath Attachment
Version Model NumberT3300
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 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
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
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Phone+1(800)401-1086
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170182990 [Primary]
GS114953170182997 [Package]
Contains: 04953170182990
Package: [3 Units]
Discontinued: 2018-03-06
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFLInstrument, ultrasonic surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


[14953170182997]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-11

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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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