StealthStation® iNav w/ AxiEM™ TechNology

GUDID 00613994231383

SOFTWARE 9733260 AXIEM CRANIAL INAV

MEDTRONIC NAVIGATION, INC.

Multi-purpose stereotactic surgery system
Primary Device ID00613994231383
NIH Device Record Key0dd48665-9274-4a0d-bdc1-8dcd14c55f4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameStealthStation® iNav w/ AxiEM™ TechNology
Version Model Number9733260
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 Perscriptiontrue
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
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
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
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
GS100613994231383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-05-27

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

00763000255565 - N/A2025-09-29 TRIAL 9734663 CLYDESDALE 14X50MM
00763000255589 - N/A2025-09-29 TRIAL 9734664 CLYDESDALE 14X55MM
00199150014699 - NavLock™2025-09-26 INST SET 9734492 SOLERA DEF UPGRADE
00199150014729 - SOLERA2025-09-26 INST SET 9735284 SOLERA NONCAN TAPS
00199150014736 - SOLERA2025-09-26 INST SET 9735285 SOLERA ILIAC TAPS A^
00763000244965 - N/A2025-09-26 SCREWDRIVER 9734274 LGY G4 STANDARD
00763000244972 - N/A2025-09-26 SCREWDRIVER 9734275 LGY G4 REDUCTION
00763000244989 - N/A2025-09-26 SCREWDRIVER 9734278 LGY G4 PEEK STANDARD

Trademark Results [StealthStation]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STEALTHSTATION
STEALTHSTATION
75025042 2191709 Live/Registered
MEDTRONIC NAVIGATION, INC.
1995-11-28

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