Provizio SEM Scanner S

GUDID 00860740002647

Provizio SEM Scanner S - Disposable Sensor Head

Bruin Biometrics, LLC

Localized oedema electrical impedance scanner
Primary Device ID00860740002647
NIH Device Record Key633040d7-dcc8-4fe9-87cc-77f75cd0253f
Commercial Distribution StatusIn Commercial Distribution
Brand NameProvizio SEM Scanner S
Version Model Number02647
Company DUNS962732025
Company NameBruin Biometrics, LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860740002647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QEFPressure Ulcer Management Tool

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-06
Device Publish Date2022-06-28

On-Brand Devices [Provizio SEM Scanner S]

00860740002647Provizio SEM Scanner S - Disposable Sensor Head
00860740002623Provizio SEM Scanner S - Disposable Sensor - Manual PTID

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