| Primary Device ID | 20613994328117 |
| NIH Device Record Key | 33089ba0-f109-41f5-8ea1-bcad460ba2de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | 945DSE1125 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 48 |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994328113 [Unit of Use] |
| GS1 | 20613994328117 [Primary] |
| GXY | ELECTRODE, CUTANEOUS |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[20613994328117]
Moist Heat or Steam Sterilization
[20613994328117]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-07-01 |
| 00613994949042 | TRAY 7069005 DUAL LEAD TAP |
| 00613994946720 | ROCKER 5484333 ROCKER EXTENDED |
| 00613994946706 | LID 7068567 CANN MAS XTRA 5.5-8.5 LID |
| 00613994946690 | MODULE 7068566 CANN MAS XTRA 5.5-8.5 MOD |
| 00613994946683 | LID 7068565 CANN MAS EXTRA 7.5 MOD LID |
| 00613994946676 | MODULE 7068564 CANN MAS EXTRA 7.5 MOD |
| 00613994946652 | DRIVER 5484339 DUAL PURPOSE DRIVER |
| 00613994946638 | PROTECTOR 2942058 18MM ENDPLATE |
| 00613994946614 | STARTER 5484338 NON-BREAKOFF PLUG |
| 00613994946607 | DRIVER 5484337 NON-BRKOFF PROVSNL INSERT |
| 00613994946591 | DRIVER 5484336 RMAS BREAKOFF |
| 00613994946515 | IMPLANT HOLDER EX0111192 5.5 STRAIGHT |
| 00613994944931 | ROD GRIPPER X0111149 90 DEGREE |
| 00613994937841 | MODIFIED X0110242 FLEX ARM |
| 00613994922274 | IMPLANT HOLDER EX1210012 6.35 STRAIGHT |
| 00613994922182 | REDUCER EX0810522 MICRO |
| 00613994912046 | INSTRUMENT 7570946 SCREW GHOST |
| 00613994912039 | INSTRUMENT 7570945 FLUOROSCOPIC RULER |
| 00613994912022 | INSTRUMENT 7570944 EXTENDER COLLAR |
| 00613994912015 | INSTRUMENT 7570942 FRACTURE REDUCER |
| 00613994912008 | INSTRUMENT 7570940 COMPRESSOR DISTRACTOR |
| 00613994909817 | 9.5 TAP X1010056 CANNULATED DUAL THREAD |
| 00613994909800 | 9.0 TAP X1010055 CANNULATED DUAL THREAD |
| 00613994909794 | 8.5 TAP X1010022 CANNULATED DUAL THREAD |
| 00613994905758 | ADAPTER 2346051 POWEREASE HANDLE ADAPTER |
| 00613994905741 | ADAPTER 2346050 POWEREASE SQUARE ADAPTER |
| 00613994904850 | GUIDEWIRE X1110004 BLUNT |
| 00613994901170 | TRAY 1207788 PREVAIL |
| 00613994901163 | HOLDER 5484391 4.75 VCM IMPLANT HOLDER |
| 00613994901057 | RETRACTOR X0810464 RACK WORM GEAR |
| 00613994898043 | TRAY 6660010 STND TRIAL LOWER |
| 00613994896384 | CRIMP X1010599 MINI REDUCTION |
| 00613994896377 | REMOVAL TOOL X1010604 MINI CRIMP |
| 00613994894953 | SPECULUM X0810494 70MM |
| 00613994894946 | SPECULUM X0810493 50MM |
| 00613994894939 | SPECULUM X0810492 30MM |
| 00613994894779 | DRILL X1010147 2.4MM BIT |
| 00613994894755 | TAP X09103869 CANNULATED 4.5 |
| 00613994894748 | TAP X09103870 CANNULATED 5.0 |
| 00613994894731 | TAP X09103871 CANNULATED 5.5 |
| 00613994894724 | TAP X09103872 CANNULATED 6.0 |
| 00613994894717 | TAP X09103873 CANNULATED 6.5 |
| 00613994894700 | TAP X09103874 CANNULATED 7.0 |
| 00613994894694 | TAP X09103875 CANNULATED 7.5 |
| 00613994894687 | TAP X09103876 CANNULATED 8.0 |
| 00613994894670 | TAP X09103877 CANNULATED 8.5 |
| 00613994894663 | TAP X09103878 CANNULATED 9.0 |
| 00613994894656 | TAP X09103879 CANNULATED 9.5 |
| 00613994888372 | TRAY 9396009 INSTTRAY3 |
| 00613994884657 | PIN X09103370 PLATE HOLDING EXTENDED |