| Primary Device ID | 00763000152611 |
| NIH Device Record Key | 13ea2d83-d59e-477f-9d9a-aaff3a2df373 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 7068023 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000152611 [Primary] |
| KCT | Sterilization wrap containers, trays, cassettes & other accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-14 |
| Device Publish Date | 2020-02-06 |
| 00763000885144 - n/a | 2026-03-20 INSTRUMENT 2900249 SHUCKER |
| 00199150066889 - Medtronic Reusable Instruments | 2026-03-10 AWL EX1125008 |
| 00199150066919 - Medtronic Reusable Instruments | 2026-03-10 ADJUSTER EX1125005 SAS HEAD |
| 00763000880422 - Endoskeleton™ TCS Interbody System | 2026-03-10 BONE SCREW 5301-3516 TCS 3.5MM STD 16MM |
| 00199150065974 - Medtronic Reusable Instruments | 2026-03-09 COUNTER TORQUE EX1125009 CLOSED |
| 00199150066902 - Medtronic Reusable Instruments | 2026-03-09 DRIVER X0925004 T8/T10 HEXALOBE |
| 00763000857936 - T2 STRATOSPHERE™ Expandable Corpectomy System | 2026-03-09 ENDCAP 4361168 16MM 8 DEGREE STERILE |
| 00199150066025 - Medtronic Reusable Instruments | 2026-03-03 DILATOR EX1125002 INITIAL LONG |