| 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 |
| 00763000764050 - OsteoCool™ 2.0 RF Ablation System | 2024-11-19 CART OCA01-100 OC 2.0 100W STAND |
| 00763000670542 - n/a | 2024-11-18 TEMPLATE 3005975 ZEVO 75MM 5 LVL |
| 00763000670559 - n/a | 2024-11-18 TEMPLATE 3005977 ZEVO 77MM 5 LVL |
| 00763000670566 - n/a | 2024-11-18 TEMPLATE 3005979 ZEVO 79MM 5 LVL |
| 00763000670573 - n/a | 2024-11-18 TEMPLATE 3005981 ZEVO 81MM 5 LVL |
| 00763000670580 - n/a | 2024-11-18 TEMPLATE 3005985 ZEVO 85MM 5 LVL |
| 00763000670597 - n/a | 2024-11-18 TEMPLATE 3005990 ZEVO 90MM 5 LVL |
| 00763000670603 - n/a | 2024-11-18 TEMPLATE 3005995 ZEVO 95MM 5 LVL |