| Primary Device ID | 20613994470984 |
| NIH Device Record Key | b07192a2-f6ff-4242-9851-c39125a6bf77 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NIM SPINE™ |
| Version Model Number | 945DME2002 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 2 |
| 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 | 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 | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994470980 [Unit of Use] |
| GS1 | 20613994470984 [Primary] |
| GXZ | ELECTRODE, NEEDLE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-04-17 |
| 00763000672645 - n/a | 2024-11-12 DRIVER 7570922 REDCTN BALL END DRVR |
| 00763000672652 - n/a | 2024-11-12 DRIVER 7570923 REDUCTION RETAIN DRVR |
| 00763000672669 - n/a | 2024-11-12 DRIVER 7570909 REDUCTION BNSCRW DRVR |
| 00763000672690 - n/a | 2024-11-12 INSTRUMENT 7570031 ROD TROCAR |
| 00763000673734 - n/a | 2024-11-12 INSTRUMENT 8572006 ROCKER |
| 00763000673864 - n/a | 2024-11-12 INSTRUMENT 8670045 SEXTANT 4.5MM TAP |
| 00763000673871 - n/a | 2024-11-12 INSTRUMENT 8670055 SEXTANT 5.5MM TAP |
| 00763000673888 - n/a | 2024-11-12 INSTRUMENT 8670065 SEXTANT 6.5MM TAP |