Probe for LUS-2 2.0mm O.D.

GUDID 04953170318818

OLYMPUS MEDICAL SYSTEMS CORP.

Ultrasonic lithotripsy system reusable
Primary Device ID04953170318818
NIH Device Record Key65f10b4f-43dd-4f40-a86d-d95121be0f7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameProbe for LUS-2 2.0mm O.D.
Version Model NumberMAJ-1216
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170318818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FEOLithotriptor, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-27
Device Publish Date2021-12-17

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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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