AccessGUDID - DEVICE: NeuroSolutions 100 (08908006064090)

GUDID

Device Identifier (DI) Information

Brand Name: NeuroSolutions 100
Version or Model: NeuroSolutions 100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DYANSYS INDIA PRIVATE LIMITED

Primary DI Number: 08908006064090
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 916731981 *Terms of Use

Device Description: NeuroSolutions 100

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:	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?
13763	Acupuncture electrical stimulation system	An electrically-powered unit designed to be used specifically to apply electrical stimuli to acupuncture sites (electroacupuncture). It is an external low-intensity, low frequency pulse (usually 1 to 100 pulses per second), multimode generator intended to connect to acupuncture electrodes. The electrodes may be placed either on the skin, or through acupuncture needles that penetrate the skin at the acupuncture points. Some may use a probe to detect the acupuncture sites using visual or audio signals.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NHI	Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 3196100b-85ba-42e0-8a5c-e27989319dc4
Public Version Date: July 29, 2024
Public Version Number: 1
DI Record Publish Date: July 19, 2024