N/A

GUDID 00643169966963

INTF KIT 9736023 ZEISS PENTERO HUD S8

MEDTRONIC NAVIGATION, INC.

Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system
Primary Device ID00643169966963
NIH Device Record Key78e4e26f-ba49-46d0-9932-5edd2847dc71
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number9736023
Company DUNS835233107
Company NameMEDTRONIC NAVIGATION, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169966963 [Primary]
GS100643169966963 [Primary]
GS100643169966963 [Primary]
GS100643169966963 [Primary]
GS100643169966963 [Primary]
GS100643169966963 [Primary]
GS100643169966963 [Primary]
GS100643169966963 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument
HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-31

On-Brand Devices [N/A]

00613994944986UPGD PRGM 9734849 S7 CPTL ENH PRGM
00613994931290MOUSE KIT 9734691XOM WIRELESS SURGEON
00613994926487TAP KIT 9734838 SOLERA 8.5 CANNULATED
00613994926241NAVLOCK KIT 9734837 VIOLET
00613994883094MOUSE KIT 9734691 WIRELESS SURGEON MOUSE
00613994878007SOFTWARE 9734332 INSTALL TOOLS 3D FLUORO
00613994877802INTERFACE KIT 9734486 ZIEHM VARIO 3D FD
00613994870063THORACIC PROBE 9734680 NAVLOCK
00613994870049AWL SHARP 9734678 NAVLOCK
00613994853516DRIVER KIT 9734644 LGY G4 STANDARD
00613994844767SET 9734378 SUPPLEMENTAL INS AXIEM ENT
00613994844750TRAY 9734320 SUPPLEMENTAL INS AXIEM ENT
00613994844743INSTRUMENT 9734311 ELEVATOR AXIEM ENT
00613994844736CURETTE 9734310 SUCTION 90 DEG AXIEM ENT
00613994844729CURETTE 9734309 SUCTION 45 DEG AXIEM ENT
00613994844712SUCTION 9734308 SMALL STRAIGHT AXIEM ENT
00613994844705SUCTION 9734307 FRONTAL 90 DEG AXIEM ENT
00613994844699SUCTION 9734306 FRONTAL 45 DEG AXIEM ENT
00613994844149SOFTWARE 9734733 S7 3D FLUORO CALIBRATN
00613994842602INST KIT 9734626 NAVLOCK SOL BASIC SPINE
00613994842596INST KIT 9734625 NAVLOCK LGY BASIC SPINE
00613994805713DRIVER 9734439 PERCUTANEOUS BALL
00613994804730TOOL 9734450 INSERTION / REMOVAL
00613994795397ENT PRGM 9734636 ADD FUSION NAV AxiEM
00613994792990UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
00613994792877DRVR KIT 9734647 SOLERA STD DRIVER
00613994792860DRVR KIT 9734648 SOLERA REDUCTION DRVR
00613994792853DRVR KIT 9734646 LGY G4 PEEK STD DRIVER
00613994792846DRVR KIT 9734649 LGY G4 PEEK RDCTN DRVR
00613994792839DRVR KIT 9734645 LGY G4 REDUCTION DRIVER
00613994792822TD SET 9734632 SOLERA STD TAPS/DRIVERS
00613994791382TD SET 9734631 LEGACY STD TAPS/DRIVERS
00613994776730SOFTWARE 9734620 MACH POLESTAR
00613994771230SCREWDRIVER 9734374 G4 PEEK REDUCTION
00613994771223SCREWDRIVER 9734373 SOLERA REDUCTION
00613994771216SCREWDRIVER 9734279 SOLERA STANDARD
00613994771193SCREWDRIVER 9734275 LGY G4 REDUCTION
00613994763464COMPUTER 9734519R BRIDGESTONE REWORK
00613994759634PROBE 9734437 RIGHT THORACIC TACTILE
00613994759610PROBE 9734435 AWL TACTILE
00613994756992PROC KIT 9734553 S7 ENT FUSION
00613994753106SOFTWARE 9734587 3D FLUORO CALIBRATION
00613994751096INST KIT 9734521 NAVLOCK SOL BASIC SPINE
00613994751089INST KIT 9734520 NAVLOCK LGY BASIC SPINE
00613994746702INST SET 9734507 UNIVERSAL DRILL GUIDE
00613994746696INST SET 9734502 REF MAST UPGRADE
00613994746689INST SET 9734501 REF PERC PIN UPGRADE
00613994746337INST SET 9734495 REFERENCING STD
00613994746320INST SET 9734494 TACTILE PROBES
00613994746313INST SET 9734493 AWL-TIP

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