| Primary Device ID | 00613994792846 |
| NIH Device Record Key | cf5a071a-80a6-4170-9e56-19d73112d8d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | 9734649 |
| Company DUNS | 835233107 |
| Company Name | MEDTRONIC NAVIGATION, 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994792846 [Primary] |
| OLO | Orthopedic stereotaxic instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-10-05 |
| Device Publish Date | 2016-06-13 |
| 00613994944986 | UPGD PRGM 9734849 S7 CPTL ENH PRGM |
| 00613994931290 | MOUSE KIT 9734691XOM WIRELESS SURGEON |
| 00613994926487 | TAP KIT 9734838 SOLERA 8.5 CANNULATED |
| 00613994926241 | NAVLOCK KIT 9734837 VIOLET |
| 00613994883094 | MOUSE KIT 9734691 WIRELESS SURGEON MOUSE |
| 00613994878007 | SOFTWARE 9734332 INSTALL TOOLS 3D FLUORO |
| 00613994877802 | INTERFACE KIT 9734486 ZIEHM VARIO 3D FD |
| 00613994870063 | THORACIC PROBE 9734680 NAVLOCK |
| 00613994870049 | AWL SHARP 9734678 NAVLOCK |
| 00613994853516 | DRIVER KIT 9734644 LGY G4 STANDARD |
| 00613994844767 | SET 9734378 SUPPLEMENTAL INS AXIEM ENT |
| 00613994844750 | TRAY 9734320 SUPPLEMENTAL INS AXIEM ENT |
| 00613994844743 | INSTRUMENT 9734311 ELEVATOR AXIEM ENT |
| 00613994844736 | CURETTE 9734310 SUCTION 90 DEG AXIEM ENT |
| 00613994844729 | CURETTE 9734309 SUCTION 45 DEG AXIEM ENT |
| 00613994844712 | SUCTION 9734308 SMALL STRAIGHT AXIEM ENT |
| 00613994844705 | SUCTION 9734307 FRONTAL 90 DEG AXIEM ENT |
| 00613994844699 | SUCTION 9734306 FRONTAL 45 DEG AXIEM ENT |
| 00613994844149 | SOFTWARE 9734733 S7 3D FLUORO CALIBRATN |
| 00613994842602 | INST KIT 9734626 NAVLOCK SOL BASIC SPINE |
| 00613994842596 | INST KIT 9734625 NAVLOCK LGY BASIC SPINE |
| 00613994805713 | DRIVER 9734439 PERCUTANEOUS BALL |
| 00613994804730 | TOOL 9734450 INSERTION / REMOVAL |
| 00613994795397 | ENT PRGM 9734636 ADD FUSION NAV AxiEM |
| 00613994792990 | UPGRD PRGM 9734638 ADD AxiEM NAVIGATION |
| 00613994792877 | DRVR KIT 9734647 SOLERA STD DRIVER |
| 00613994792860 | DRVR KIT 9734648 SOLERA REDUCTION DRVR |
| 00613994792853 | DRVR KIT 9734646 LGY G4 PEEK STD DRIVER |
| 00613994792846 | DRVR KIT 9734649 LGY G4 PEEK RDCTN DRVR |
| 00613994792839 | DRVR KIT 9734645 LGY G4 REDUCTION DRIVER |
| 00613994792822 | TD SET 9734632 SOLERA STD TAPS/DRIVERS |
| 00613994791382 | TD SET 9734631 LEGACY STD TAPS/DRIVERS |
| 00613994776730 | SOFTWARE 9734620 MACH POLESTAR |
| 00613994771230 | SCREWDRIVER 9734374 G4 PEEK REDUCTION |
| 00613994771223 | SCREWDRIVER 9734373 SOLERA REDUCTION |
| 00613994771216 | SCREWDRIVER 9734279 SOLERA STANDARD |
| 00613994771193 | SCREWDRIVER 9734275 LGY G4 REDUCTION |
| 00613994763464 | COMPUTER 9734519R BRIDGESTONE REWORK |
| 00613994759634 | PROBE 9734437 RIGHT THORACIC TACTILE |
| 00613994759610 | PROBE 9734435 AWL TACTILE |
| 00613994756992 | PROC KIT 9734553 S7 ENT FUSION |
| 00613994753106 | SOFTWARE 9734587 3D FLUORO CALIBRATION |
| 00613994751096 | INST KIT 9734521 NAVLOCK SOL BASIC SPINE |
| 00613994751089 | INST KIT 9734520 NAVLOCK LGY BASIC SPINE |
| 00613994746702 | INST SET 9734507 UNIVERSAL DRILL GUIDE |
| 00613994746696 | INST SET 9734502 REF MAST UPGRADE |
| 00613994746689 | INST SET 9734501 REF PERC PIN UPGRADE |
| 00613994746337 | INST SET 9734495 REFERENCING STD |
| 00613994746320 | INST SET 9734494 TACTILE PROBES |
| 00613994746313 | INST SET 9734493 AWL-TIP |