| Primary Device ID | 07290110483098 |
| NIH Device Record Key | 6c0b3189-05f9-4a3e-9b7b-8284a19bd30a |
| Commercial Distribution Discontinuation | 2017-09-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | NESS L300 Foot Drop System |
| Version Model Number | LG3-5U00 |
| Catalog Number | 501-00170-01 |
| Company DUNS | 182287727 |
| Company Name | BIONESS INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +97297907100 |
| info@bioness.co.il |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290110483098 [Primary] |
| IPF | Stimulator, muscle, powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2017-02-02 |
| 07290110483098 | Small L300 System Kit, Right US |
| 07290110483081 | Small L300 System Kit, Left US |
| 07290110483074 | Regular L300 Clinician's Kit US |
| 07290110483067 | Regular L300 System Kit, Right US |
| 07290110483050 | Regular L300 System Kit, Left US |