| Primary Device ID | 00763000913885 |
| NIH Device Record Key | 36b46465-a198-446f-ba30-c457359aa9dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MSB Reusable Instruments |
| Version Model Number | X0423001 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000913885 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000913885]
Moist Heat or Steam Sterilization
[00763000913885]
Moist Heat or Steam Sterilization
[00763000913885]
Moist Heat or Steam Sterilization
[00763000913885]
Moist Heat or Steam Sterilization
[00763000913885]
Moist Heat or Steam Sterilization
[00763000913885]
Moist Heat or Steam Sterilization
[00763000913885]
Moist Heat or Steam Sterilization
[00763000913885]
Moist Heat or Steam Sterilization
[00763000913885]
Moist Heat or Steam Sterilization
[00763000913885]
Moist Heat or Steam Sterilization
[00763000913885]
Moist Heat or Steam Sterilization
[00763000913885]
Moist Heat or Steam Sterilization
[00763000913885]
Moist Heat or Steam Sterilization
[00763000913885]
Moist Heat or Steam Sterilization
[00763000913885]
Moist Heat or Steam Sterilization
[00763000913885]
Moist Heat or Steam Sterilization
[00763000913885]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-26 |
| Device Publish Date | 2024-02-18 |
| 00763000760250 | DRIVER EX0922015 6.35MM PROVISIONAL SHRT |
| 00763000642303 | SHAVER EX1221020 PADDLE DISTRACTOR 6MM |
| 00763000648848 | RETRACTOR X0821031 HAND HELD TISSUE |
| 00763000876623 | BOX CHISEL EX0623001 6MM W/CORONAL BEND |
| 00763000583477 | PROBE 5597035 MAZOR BAYONET FEELER |
| 00763000638429 | BLADE X07214110 CRANIAL CAUDAL R L110MM |
| 00763000913885 | GUARD X0423001 RIALTO DTS |
| 00763000916145 | SCREWDRIVER EX0223017 CERVICAL |
| 00763000940447 | TRIAL X0420012 16DEG 14MM LARGE |
| 00763000914110 | OSTEOTOME EX0823012 1/2 WIDE SHARP |
| 00763000914103 | OSTEOTOME EX0823011 1/4 WIDE SHARP |
| 00763000242503 | GRAFT DELIVERY 6061007 GUN HANDLE |
| 00763000920159 | SPREADER EX0323002 LAMINA ANGLED |
| 00763000917975 | RETRACTOR EX0823013 HAND HELD TISSUE |
| 00613994104441 | INSTRUMENT X0805222 RIGHT HALF TUBE90MM |
| 00763000700485 | OSTEOTOME EX0222042 STRAIGHT 12.7MM |
| 00763000658687 | HOLDER EX0322005 PLATE |
| 00681490480758 | INSTRUMENT 1766106 DISTRACTION FORCEPS |
| 00763000864835 | TEMPLATE 4361316 13MM/16MM TEMPLATE |
| 00613994789778 | OSTEOTOME X0410081 STRAIGHT |
| 00681490520102 | INSTRUMENT 8756416 DISTRACTOR PIN 16MM |
| 00643169714687 | EXTENDER 5580130 OPEN |
| 00763000242510 | GRAFT DELIVERY 6061020 LOADING PLATFORM |