| Primary Device ID | 00763000139988 |
| NIH Device Record Key | 4bd8c82f-6713-4f7b-9c58-ccda6ac76292 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 9564001 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000139988 [Primary] |
| GAD | RETRACTOR |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000139988]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-21 |
| Device Publish Date | 2019-06-13 |
| 00763000273804 - n/a | 2025-10-06 SCREWDRIVER 3606201 TORQUE LIMIT SHAFT |
| 00763000875282 - SHILLA™ Growth Guidance System | 2025-10-06 SCREW 7675430 5.5 SHILLA MAS CANN 4.5X30 |
| 00763000884956 - n/a | 2025-10-06 LOCK SCREW DRIVER 7080930 TRI-FLAT |
| 00885074240695 - n/a | 2025-09-30 ACCESSORIES 3299003 GRAFT TAMP |
| 00199150026029 - Medtronic Reusable Instruments | 2025-09-29 COMPRESSOR X0525001 RACK AND PINION |
| 00763000684044 - Medtronic Reusable Instruments | 2025-09-29 INSTRUMENT 950-146 RULER |
| 00763000856700 - VERTE-STACK® Spinal System | 2025-09-29 STRUT 6242064 ANATOMIC 16X14X24MM |
| 00763000879563 - ENDOSKELETON® TCS | 2025-09-29 HANDLE 5210-1016 TCS RATCHETING HANDLE |