Primary Device ID | 00613994513960 |
NIH Device Record Key | b204b72b-d3d0-4319-b718-af3eeb7d7958 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | N/A |
Version Model Number | 945MNP2001 |
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 | 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 | |
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 | 00613994513960 [Primary] |
ETN | STIMULATOR, NERVE |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-04-17 |
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 |