| Primary Device ID | 09369998075812 |
| NIH Device Record Key | da7efd6c-96ad-438e-b1d0-dc7d1941a0d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NervAlign Nerve Cuff |
| Version Model Number | NA-NC1010 |
| Catalog Number | NA-NC1010 |
| Company DUNS | 744429508 |
| Company Name | RENERVE LIMITED |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09369998075812 [Primary] |
| JXI | Cuff, 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 | 2022-04-18 |
| Device Publish Date | 2022-04-08 |
| 09369998231904 | An absorbable collagen membrane implant that provides non-constricting protection for peripheral |
| 09369998146796 | An absorbable collagen membrane implant that provides non-constricting protection for peripheral |
| 09369998075812 | An absorbable collagen membrane implant that provides non-constricting protection for peripheral |