| Primary Device ID | 10860013827103 |
| NIH Device Record Key | b2e241b3-4e9e-4082-8597-5b2faea8fb08 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Evala nerve stimulator |
| Version Model Number | EPNR002 |
| Company DUNS | 208240384 |
| Company Name | Epineuron Technologies Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 9052060466 |
| info@epineurontech.com | |
| Phone | 9052060466 |
| info@epineurontech.com | |
| Phone | 9052060466 |
| info@epineurontech.com | |
| Phone | 9052060466 |
| info@epineurontech.com | |
| Phone | 9052060466 |
| info@epineurontech.com | |
| Phone | 9052060466 |
| info@epineurontech.com | |
| Phone | 9052060466 |
| info@epineurontech.com | |
| Phone | 9052060466 |
| info@epineurontech.com | |
| Phone | 9052060466 |
| info@epineurontech.com | |
| Phone | 9052060466 |
| info@epineurontech.com | |
| Phone | 9052060466 |
| info@epineurontech.com | |
| Phone | 9052060466 |
| info@epineurontech.com |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860013827106 [Primary] |
| GS1 | 10860013827103 [Package] Contains: 00860013827106 Package: shelf box [1 Units] In Commercial Distribution |
| ETN | Stimulator, Nerve |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-25 |
| Device Publish Date | 2026-03-17 |