| Primary Device ID | 00763000152628 |
| NIH Device Record Key | b799a31d-5f7b-4608-97ba-7bac586ca9d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 7068031 |
| 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 | 00763000152628 [Primary] |
| KCT | Sterilization wrap containers, trays, cassettes & other accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
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 |
| 00763000663865 - n/a | 2025-07-28 DRILL BIT 7080513 STERILE 13MM |
| 00763000856472 - Pyramesh® Implant System | 2025-07-28 MESH 905-412 PYRM 10 X 14 OVOID X 12MM |
| 00763000856489 - Pyramesh® Implant System | 2025-07-28 MESH 905-415 PYRM 10 X 14 OVOID X 15MM |
| 00763000856502 - Pyramesh® Implant System | 2025-07-28 MESH 905-508 PYRM 13 X 17 OVOID X 8MM |
| 00763000856519 - Pyramesh® Implant System | 2025-07-28 MESH 905-509 PYRM 13 X 17 OVOID X 9MM |
| 00763000856526 - Pyramesh® Implant System | 2025-07-28 MESH 905-511 PYRM 13 X 17 OVOID X 11MM |
| 00763000856533 - Pyramesh® Implant System | 2025-07-28 MESH 905-512 PYRM 13 X 17 OVOID X 12MM |
| 00763000856557 - Pyramesh® Implant System | 2025-07-28 MESH 905-520 PYRM 13 X 17 OVOID X 20MM |