| Primary Device ID | 00763000250263 |
| NIH Device Record Key | 24d9c067-f4fb-4fd0-96e0-663383382ff4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SureTrak® |
| Version Model Number | 9735326 |
| Company DUNS | 835233107 |
| Company Name | MEDTRONIC NAVIGATION, 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000250263 [Primary] |
| MAX | Intervertebral fusion device with bone graft, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000250263]
Moist Heat or Steam Sterilization
[00763000250263]
Moist Heat or Steam Sterilization
[00763000250263]
Moist Heat or Steam Sterilization
[00763000250263]
Moist Heat or Steam Sterilization
[00763000250263]
Moist Heat or Steam Sterilization
[00763000250263]
Moist Heat or Steam Sterilization
[00763000250263]
Moist Heat or Steam Sterilization
[00763000250263]
Moist Heat or Steam Sterilization
[00763000250263]
Moist Heat or Steam Sterilization
[00763000250263]
Moist Heat or Steam Sterilization
[00763000250263]
Moist Heat or Steam Sterilization
[00763000250263]
Moist Heat or Steam Sterilization
[00763000250263]
Moist Heat or Steam Sterilization
[00763000250263]
Moist Heat or Steam Sterilization
[00763000250263]
Moist Heat or Steam Sterilization
[00763000250263]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-18 |
| Device Publish Date | 2020-05-09 |
| 00643169345157 | INST KIT 9735326 SURETRAK II LARGE CLAMP |
| 00643169345140 | INST KIT 9735325 SURETRAK II SM FIGHTER |
| 00763000205973 | INST KIT 9735326 SURETRAK II LARGE CLAMP |
| 00763000205966 | INST KIT 9735325 SURETRAK II SM FIGHTER |
| 00763000250263 | INST KIT 9735326 SURETRAK II LARGE CLAMP |