Viera Portable Breast Ultrasound 81-02-00024; 81-02-00002

GUDID 07540205000649

Clarius Mobile Health Corp

Hand-held ultrasound imaging system, body-surface
Primary Device ID07540205000649
NIH Device Record Key2a503507-b426-407f-aee8-e9a9bf6026ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameViera Portable Breast Ultrasound
Version Model NumberViera Battery Charger
Catalog Number81-02-00024; 81-02-00002
Company DUNS202522751
Company NameClarius Mobile Health 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107540205000649 [Direct Marking]
GS107540205000687 [Primary]
GS107540205000694 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-21
Device Publish Date2018-03-27

On-Brand Devices [Viera Portable Breast Ultrasound]

07540205000649Viera Battery Charger
07540205000106Viera Portable Breast Ultrasound Linear Scanner

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