StealthStation® Cranial

GUDID 00763000299972

SW KIT 9735586 STEALTHSTATION CRANIAL

MEDTRONIC NAVIGATION, INC.

Neurological stereotactic surgery system
Primary Device ID00763000299972
NIH Device Record Key0d2a9439-6ca4-4206-93bc-37c317a11f8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameStealthStation® Cranial
Version Model Number9735586
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000299972 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-04
Device Publish Date2019-10-27

On-Brand Devices [StealthStation® Cranial]

00643169625631SW KIT 9735587 STEALTH CRANIAL PLNG STN
00643169625570SW KIT 9735586 STEALTHSTATION CRANIAL
00643169625532SOFTWARE 9735585 STEALTHSTATION CRANIAL
00763000095819SW KIT 9735587 STEALTH CRANIAL PLNG STN
00763000095758SW KIT 9735586 STEALTHSTATION CRANIAL
00763000095741SOFTWARE 9735585 STEALTHSTATION CRANIAL
00763000253165SOFTWARE 9735585 STEALTHSTATION CRANIAL
00763000299972SW KIT 9735586 STEALTHSTATION CRANIAL
00763000299927SW KIT 9735587 STEALTH CRANIAL PLNG STN
00763000517335SWKT 9735587 STLTH CRAN 3.1.3 PLNG STN
00763000517274SWKT 9735586 STEALTH CRANIAL 3.1.3
00763000631826SWKT 9735587 STLTH CRAN 3.1.4 PLNG STN
00763000631765SWKT 9735586 STEALTH CRANIAL 3.1.4

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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