StealthAiR™ Spine

GUDID 00763000416805

SFW KIT 9736350 STEALTH AIR

MEDTRONIC NAVIGATION, INC.

Neurological stereotactic surgery system
Primary Device ID00763000416805
NIH Device Record Key1f4a1950-9070-46f1-93b9-6e8816fb64ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameStealthAiR™ Spine
Version Model Number9736350
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000416805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-26
Device Publish Date2020-10-16

On-Brand Devices [StealthAiR™ Spine]

00763000385637SFW KIT 9736350 STEALTHAIR SPINE
00763000416805SFW KIT 9736350 STEALTH AIR

Trademark Results [StealthAiR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STEALTHAIR
STEALTHAIR
85702342 4316809 Live/Registered
Medtronic Navigation, Inc.
2012-08-13
STEALTHAIR
STEALTHAIR
85178881 not registered Dead/Abandoned
Medtronic Navigation, Inc.
2010-11-17

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