PROVE (STRAIGHT)

GUDID 14953170183130

OLYMPUS MEDICAL SYSTEMS CORP.

Soft-tissue ultrasonic surgical system
Primary Device ID14953170183130
NIH Device Record Keyc9509414-c5d9-471d-9a84-2f52e3fe7ac3
Commercial Distribution Discontinuation2018-03-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePROVE (STRAIGHT)
Version Model NumberMH-112
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 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
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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
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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
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
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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
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
Emailxx@xx.xx
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
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170183133 [Primary]
GS114953170183130 [Package]
Contains: 04953170183133
Package: [1 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

[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


[14953170183130]

Moist Heat or Steam Sterilization;Ethylene Oxide


Device Entry Metadata

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

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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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