| Primary Device ID | 00643169316515 |
| NIH Device Record Key | f64ebfe3-e99f-46ab-bf19-35682b3713ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medtronic Reusable Instruments |
| Version Model Number | X1012425 |
| 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 | 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 |
| Angle | 0 degree |
| Angle | 0 degree |
| Angle | 0 degree |
| Angle | 0 degree |
| Angle | 0 degree |
| Angle | 0 degree |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169316515 [Primary] |
| MAX | Intervertebral fusion device with bone graft, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169316515]
Moist Heat or Steam Sterilization
[00643169316515]
Moist Heat or Steam Sterilization
[00643169316515]
Moist Heat or Steam Sterilization
[00643169316515]
Moist Heat or Steam Sterilization
[00643169316515]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2015-06-30 |
| 00613994900999 | DISTRACTOR/TRIAL X1010843 6X26 |
| 00613994900982 | DISTRACTOR/TRIAL X1010842 6X22 |
| 00613994898500 | DISTRACTOR/TRIAL X09103461 12 X 8 X 22 |
| 00613994898494 | DISTRACTOR/TRIAL X09103462 12 X 8 X 26 |
| 00613994898487 | DISTRACTOR/TRIAL X09103463 12 X 8 X 32 |
| 00613994898470 | DISTRACTOR/TRIAL X09103464 12 X 8 X 36 |
| 00613994898463 | DISTRACTOR/TRIAL X09103465 12 X 10 X 22 |
| 00613994898456 | DISTRACTOR/TRIAL X09103466 12 X 10 X 26 |
| 00613994898449 | DISTRACTOR/TRIAL X09103467 12 X 10 X 32 |
| 00613994898432 | DISTRACTOR/TRIAL X09103468 12 X 10 X 36 |
| 00613994898425 | DISTRACTOR/TRIAL X09103469 12 X 12 X 22 |
| 00613994898418 | DISTRACTOR/TRIAL X09103470 12 X 12 X 26 |
| 00613994898401 | DISTRACTOR/TRIAL X09103471 12 X 12 X 32 |
| 00613994898395 | DISTRACTOR/TRIAL X09103472 12 X 12 X 36 |
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| 00613994898364 | DISTRACTOR/TRIAL X09103475 12 X 14 X 32 |
| 00613994898357 | DISTRACTOR/TRIAL X09103476 12 X 14 X 36 |
| 00613994898340 | DISTRACTOR/TRIAL X09103477 12 X 16 X 22 |
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| 00613994898326 | DISTRACTOR/TRIAL X09103479 12 X 16 X 32 |
| 00613994898319 | DISTRACTOR/TRIAL X09103480 12 X 16 X 36 |
| 00613994808257 | SCREW PFF0040 40MM FACET FIXATION ANCHOR |
| 00613994808240 | SCREW PFF0035 35MM FACET FIXATION ANCHOR |
| 00613994808233 | SCREW PFF0030 30MM FACET FIXATION ANCHOR |
| 00613994808226 | SCREW PFF0025 25MM FACET FIXATION ANCHOR |
| 00613994806291 | TRIAL 2981126 CAPSTONE 11 X 26MM |
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| 00613994806277 | TRIAL 2980936 CAPSTONE 09 X 36MM |
| 00613994806260 | TRIAL 2980932 CAPSTONE 09 X 32MM |
| 00613994806253 | TRIAL 2980926 CAPSTONE 09 X 26MM |
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| 00613994806215 | TRIAL 2980726 CAPSTONE 07 X 26MM |
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| 00613994806055 | TRIAL 2981326 CAPSTONE 13 X 26MM |
| 00613994806048 | TRIAL 2981322 CAPSTONE 13 X 22MM |
| 00613994806031 | TRIAL 2981136 CAPSTONE 11 X 36MM |