ARC-EX System

Basic Information

• Brand Name: ARC-EX System
• Primary DI: 08720908310002
• Version / Model: ARC-EX System - Professional US
• Catalog Number: EXSYS01PROUS
• Company Name: ONWARD Medical N.V.
• Labeler DUNS: 491823169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-27
• Public Version: 1
• Public Version Date: 2025-01-06
• Public Version Status: New
• Public Device Record Key: 9b7696ad-d5c3-4d2c-a9c4-b8a3b3ce122f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SDO	Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation	Physical Medicine	890.5851	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	08720908310040	GS1
Primary	08720908310002	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -13 – 158 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal