AccessGUDID - DEVICE: ARC-EX System (08720908310002)

GUDID

Device Identifier (DI) Information

Brand Name: ARC-EX System
Version or Model: ARC-EX System - Professional US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EXSYS01PROUS
Company Name: ONWARD Medical N.V.

Primary DI Number: 08720908310002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 491823169 *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?
66826	Spinal cord rehabilitation transcutaneous electrical stimulation system	An electrically-powered device assembly intended to apply various modes of transcutaneous electrical stimulation to the spinal cord to improve or restore upper extremity sensory and motor function in adults with chronic neurological deficit resulting from incomplete spinal cord injury. It includes a portable electric current pulse generator and noninvasive electrodes. It is intended for use in the healthcare facility and in the home.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
SDO	Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -13 and 158 Degrees Fahrenheit
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9b7696ad-d5c3-4d2c-a9c4-b8a3b3ce122f
Public Version Date: January 06, 2025
Public Version Number: 1
DI Record Publish Date: December 27, 2024