| Primary Device ID | 00763000152604 |
| NIH Device Record Key | d3613509-7e59-48a2-846f-54c938c8ce7e |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 7068022 |
| 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 | 00763000152604 [Primary] |
| KCT | Sterilization wrap containers, trays, cassettes & other accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
Moist Heat or Steam Sterilization
[00763000152604]
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 |
| 00643169281165 - CD HORIZON® ASTUTE™ SPINAL SYSTEM | 2024-05-27 PEEK ROD 1608451070 6.0 X 6.9MM STR 70MM |
| 00763000242503 - MSB Reusable Instruments | 2024-05-27 GRAFT DELIVERY 6061007 GUN HANDLE |
| 00763000914103 - MSB Reusable Instruments | 2024-05-27 OSTEOTOME EX0823011 1/4 WIDE SHARP |
| 00763000914110 - MSB Reusable Instruments | 2024-05-27 OSTEOTOME EX0823012 1/2 WIDE SHARP |
| 00763000940454 - Medtronic Reusable Instruments | 2024-05-27 TRIAL X0420013 16DEG 16MM LARGE |
| 00763000940607 - Medtronic Reusable Instruments | 2024-05-27 TRIAL X0420028 20DEG 14MM LARGE |
| 00763000940614 - Medtronic Reusable Instruments | 2024-05-27 TRIAL X0420029 20DEG 16MM LARGE |
| 00763000940621 - Medtronic Reusable Instruments | 2024-05-27 TRIAL X0420030 20DEG 18MM LARGE |