Primary Device ID | 00763000573263 |
NIH Device Record Key | c859a84e-1b36-43e2-bbed-7a8c11c83734 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | N/A |
Version Model Number | 9731203 |
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 | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000573263 [Primary] |
HAW | Neurological stereotaxic Instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-04-11 |
Device Publish Date | 2022-04-02 |
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 |