AccessGUDID - DEVICE: MyndMove (00692520001225)

GUDID

Device Identifier (DI) Information

Brand Name: MyndMove
Version or Model: MyndMove Electrode Cable Blue
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900122
Company Name: MyndTec Inc

Primary DI Number: 00692520001225
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203019245 *Terms of Use
Previous DI: 06925209001228

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
59690	Neuromuscular transmission electrode/sensor lead	A non-sterile insulated metal wire(s) designed to conduct electrical signals between neuromuscular transmission (NMT) electrodes and sensors placed on a patient's body and a patient monitoring system module, intended for the monitoring of patient relaxation to determine the level of neuromuscular block and the localization of a nerve in an area of the body. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
IPF	Stimulator, Muscle, Powered
GZI	Stimulator, Neuromuscular, External Functional

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170564	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: 80a2a79c-ceea-45a1-9bf3-16dc5d6447bd
Public Version Date: December 19, 2019
Public Version Number: 1
DI Record Publish Date: December 11, 2019