Viera Portable Breast Ultrasound 81-02-00011; 50-02-00006

GUDID 07540205000106

Clarius Mobile Health Corp

Hand-held ultrasound imaging system, body-surface
Primary Device ID07540205000106
NIH Device Record Key973af822-8252-4fdb-8dbe-f148f7b75d73
Commercial Distribution StatusIn Commercial Distribution
Brand NameViera Portable Breast Ultrasound
Version Model NumberViera Portable Breast Ultrasound Linear Scanner
Catalog Number81-02-00011; 50-02-00006
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
GS107540205000045 [Primary]
GS107540205000106 [Direct Marking]
GS107540205000205 [Primary]
GS107540205000557 [Primary]
GS107540205000601 [Primary]
GS107540205000670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.