| Primary Device ID | 00763000152659 |
| NIH Device Record Key | 5bb1ab59-7cd3-44f0-a5eb-9ed891b16816 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 7068027 |
| 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 | 00763000152659 [Primary] |
| KCT | Sterilization wrap containers, trays, cassettes & other accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
Moist Heat or Steam Sterilization
[00763000152659]
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 |
| 00763000085353 - ARTiC-L™ Spinal System | 2024-06-28 TRIAL 5251100 L 25 HT 11 DEG 0 FIXED |
| 00763000700485 - MSB Reusable Instruments | 2024-06-28 OSTEOTOME EX0222042 STRAIGHT 12.7MM |
| 00613994104441 - MSB Reusable Instruments | 2024-06-24 INSTRUMENT X0805222 RIGHT HALF TUBE90MM |
| 00763000359720 - CD HORIZON® Spinal System | 2024-06-24 MODULE 7050534R CDHL HOOK STAGING MOD |
| 00763000917975 - MSB Reusable Instruments | 2024-06-24 RETRACTOR EX0823013 HAND HELD TISSUE |
| 00763000920159 - MSB Reusable Instruments | 2024-06-24 SPREADER EX0323002 LAMINA ANGLED |
| 00885074417615 - CAPSTONE® Spinal System | 2024-06-24 INSERTER X0105157 THREADED |
| 00885074309620 - n/a | 2024-06-03 INSTRUMENT 6971105 SHIM DISTRACTOR 5MM |