ARC-EX System
- Primary DI
- 08720908310033
- Brand
- ARC-EX System
- Company
- ONWARD Medical N.V.
- Model
- ARC-EX System - Personal US
- Catalog number
- EXSYS01PERUS
- Published
- 2025-12-05
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| SDO | Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| SDO | Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation | Physical Medicine | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08720908310033 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08720908310033 | 08720908310033 | 8720908310033 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Atmospheric Pressure | 70 KiloPascal | 106 KiloPascal | |
| Storage Environment Humidity | 0 Percent (%) Relative Humidity | 90 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -13 Degrees Fahrenheit | 158 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 491823169
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 08720908310040 | ARC-EX System | ARC-EX System - Professional US | EXSYS01PROUS | 2024-12-27 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 08720908310040 | ARC-EX System | ONWARD Medical N.V. | SDO | 2024-12-27 |
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