DataLINK Management + Analysis Software (Version 1

GUDID 05060481691949

The Biometrics Analysis Software is a comprehensive tool for EMG, Goniometer and associated sensor analysis including real-time data analysis as the d

BIOMETRICS LIMITED

Bio-energy mapping system application software
Primary Device ID05060481691949
NIH Device Record Key67e8ab21-97e7-4a33-af0b-df391a324d73
Commercial Distribution StatusIn Commercial Distribution
Brand NameDataLINK Management + Analysis Software (Version 1
Version Model Number310xx-11
Company DUNS519969810
Company NameBIOMETRICS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
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
GS105060481691949 [Primary]

FDA Product Code

IKKSystem, Isokinetic Testing And Evaluation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-10
Device Publish Date2018-08-10

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