AccessGUDID - DEVICE: MyndMove (00692520001676)

GUDID

Device Identifier (DI) Information

Brand Name: MyndMove
Version or Model: MyndMove Electrode 5cm x 5cm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900167
Company Name: MyndTec Inc

Primary DI Number: 00692520001676
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203019245 *Terms of Use
Previous DI: 06925209001679

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:	Yes
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?
59689	Neuromuscular transmission electrode	A non-sterile electrical conductor designed to be applied to a patient's body surface, typically the forearm or ankle, to deliver stimulating electrical pulses to a motor nerve or measure electrical impulses from the nerve during neuromuscular transmission (NMT) monitoring. It is typically a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled) intended to be used for neuromuscular block monitoring and nerve stimulation for brachial plexus anaesthesia. This is a single-use 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: 5bdff1a8-9e59-4deb-a49b-185ee73644e2
Public Version Date: December 19, 2019
Public Version Number: 1
DI Record Publish Date: December 11, 2019