| Primary Device ID | 00643169245136 |
| NIH Device Record Key | 0367040a-84fa-4c52-85b8-1f1c4145f9d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WAVE D SPINAL SYSTEM |
| Version Model Number | 2671209 |
| 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 |
| Angle | 12 degree |
| Angle | 12 degree |
| Angle | 12 degree |
| Angle | 12 degree |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169245136 [Primary] |
| MAX | Intervertebral fusion device with bone graft, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169245136]
Moist Heat or Steam Sterilization
[00643169245136]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2015-06-30 |
| 00643169400535 | DISTRACTOR X0113137 WAVE D 6D 13X28 |
| 00643169400528 | DISTRACTOR X0113136 WAVE D 6D 12X28 |
| 00643169400511 | DISTRACTOR X0113135 WAVE D 6D 11X28 |
| 00643169400504 | DISTRACTOR X0113134 WAVE D 6D 10X28 |
| 00643169333956 | CAGE X0113133 WAVE D IB 6D 13X28 |
| 00643169333949 | CAGE X0113132 WAVE D IB 6D 12X28 |
| 00643169333932 | CAGE X0113131 WAVE D IB 6D 11X28 |
| 00643169333925 | CAGE X0113130 WAVE D IB 6D 10X28 |
| 00643169245419 | INSERTER 2670002 WAVE OUTER TUBE |
| 00643169245402 | INSERTER 2670001 WAVE INNER TUBE |
| 00643169245396 | DISTRACTOR 2671214 DSTCTR WAVE 14MM12DEG |
| 00643169245389 | DISTRACTOR 2671213 DSTCTR WAVE 13MM12DEG |
| 00643169245372 | CAP 2670015 WAVE IMPACTOR INSERTER CAP |
| 00643169245358 | THANDLE 2670012 DISTRACTOR T-HANDLE LONG |
| 00643169245341 | THANDLE 2670011 T-HANDLE FOR DISTRACTOR |
| 00643169245310 | ROD 2670005 WAVE DISTRACTION ROD 28 MM |
| 00643169245303 | ROD 2670004 WAVE DISTRACTION ROD 24 MM |
| 00643169245297 | HANDLE 2670003 WAVE DISTRACTION HANDLE |
| 00643169245280 | CAGE 2621324 WAVE D 13MM X 24MM 12DEG |
| 00643169245273 | CAGE 2621424 WAVE D 14MM X 24MM 12DEG |
| 00643169245266 | CAGE 2661424 WAVE D 14MM X 24MM 6DEG |
| 00643169245259 | CAGE 2661324 WAVE D 13MM X 24MM 6DEG |
| 00643169245242 | CAGE 2621224 WAVE D 12MM X 24MM 12DEG |
| 00643169245235 | CAGE 2661224 WAVE D 12MM X 24MM 6DEG |
| 00643169245228 | CAGE 2621124 WAVE D 11MM X 24MM 12DEG |
| 00643169245211 | CAGE 2661124 WAVE D 11MM X 24MM 6DEG |
| 00643169245204 | CAGE 2621024 WAVE D 10MM X 24MM 12DEG |
| 00643169245198 | CAGE 2661024 WAVE D 10MM X 24MM 6DEG |
| 00643169245181 | CAGE 2620924 WAVE D 9MM X 24MM 12DEG |
| 00643169245174 | CAGE 2660924 WAVE D 9MM X 24MM 6DEG |
| 00643169245167 | DISTRACTOR 2671212 DSTCTR WAVE 12MM12DEG |
| 00643169245150 | DISTRACTOR 2671211 DSTCTR WAVE 11MM12DEG |
| 00643169245143 | DISTRACTOR 2671210 DSTCTR WAVE 10MM12DEG |
| 00643169245136 | DISTRACTOR 2671209 DSTCTR WAVE 9MM 12DEG |
| 00643169245129 | DISTRACTOR 2670614 DSTCTR WAVE 14MM 6DEG |
| 00643169245112 | DISTRACTOR 2670613 DSTCTR WAVE 13MM 6DEG |
| 00643169245105 | DISTRACTOR 2670612 DSTCTR WAVE 12MM 6DEG |
| 00643169245099 | DISTRACTOR 2670611 DSTCTR WAVE 11MM 6DEG |
| 00643169245082 | DISTRACTOR 2670610 DSTCTR WAVE 10MM 6DEG |
| 00643169245075 | DISTRACTOR 2670609 DSTCTR WAVE 9MM 6DEG |
| 00643169245051 | PESTLE 2670008 WAVE PESTLE |
| 00643169245044 | FUNNEL 2670007 WAVE FUNNEL |