AccessGUDID - DEVICE: MyoVision DynaVision Dynamic sEMG (00864021000346)

GUDID

Device Identifier (DI) Information

Brand Name: MyoVision DynaVision Dynamic sEMG
Version or Model: D6
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D6
Company Name: PRECISION BIOMETRICS INC

Primary DI Number: 00864021000346
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 362997926 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32521	Multiple physiological signal amplifier	An electronic device that increases current, voltage, or power to adjust the signal level and impedance between two or more medical devices transmitting physiological signals; or the device has the capability of being used for more than a single application, such as electroencephalography (EEG), evoked potential, polysomnography (sleep analysis) and general polygraphy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQX	Goniometer, Ac-Powered
HCS	Device, Temperature Measurement, Direct Contact, Powered
HCC	Device, Biofeedback
IKN	Electromyograph, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123399	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9d57d8ab-62fe-496e-8686-d0763f7b4f79
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 15, 2016