ScanVision electrodes

GUDID 00853818007248

Static sEMG electrodes for ScanVisions (wireless static sEMG scanners)

PRECISION BIOMETRICS INC

Electrocardiographic electrode, single-use
Primary Device ID00853818007248
NIH Device Record Keyed4be987-96db-4d9b-9739-223c7df8e8e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameScanVision electrodes
Version Model NumberPB-212
Company DUNS362997926
Company NamePRECISION BIOMETRICS INC
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 Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS100853818007224 [Primary]
GS100853818007231 [Package]
Contains: 00853818007224
Package: Bag [10 Units]
In Commercial Distribution
GS100853818007248 [Package]
Contains: 00853818007231
Package: Box [12 Units]
In Commercial Distribution
GS100853818007408 [Package]
Contains: 00853818007224
Package: Bag [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IKNElectromyograph, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-13

Devices Manufactured by PRECISION BIOMETRICS INC

10853818007504 - USB C Adapter2024-09-11 PB-210-1, USB C to A adapter
00853818007491 - USB A to C Cable2024-09-11 PB-209, USB A to C cable
00853818007507 - USB C to C Cable2024-09-11 PB-210, USB C to C cable
00853818007477 - MyoVision Software2022-11-18 Software
00853818007460 - MyoVision Wirefree System2021-05-25 VisionHUB with DynaVision Dynamic sEMG
00853818007422 - SERIES-5 MyoVision Full System2021-03-08 VisionHub with FlexVision Inclinometers, DynaVision Dynamic sEMG and ScanVision Static sEMG Scanner
00853818007439 - SERIES-5 MyoVision ScanVision2021-03-08 SERIES-5 VisionHUB with ScanVision Static sEMG Scanner
00853818007446 - SERIES-5 MyoVision ScanVision2021-03-08 SERIES-5 VisionHUB with ScanVision Static sEMG Scanners

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