StealthStation Cranial Software

GUDID 00763000125295

SFW 9735762 APP STEALTH S8 APPLICATION

MEDTRONIC NAVIGATION, INC.

Multi-purpose stereotactic surgery system

• Primary Device ID: 00763000125295
• NIH Device Record Key: 556e89cf-4fd2-45f3-9e5a-4f0d38bb9f13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StealthStation Cranial Software
• Version Model Number: 9735762
• 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: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000125295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170018

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-30
• Device Publish Date: 2018-06-29

On-Brand Devices [StealthStation Cranial Software]

• 00643169931329: SFW KIT 9735916 S8 CRANIAL PLAN STATION
• 00643169921917: SFW KIT 9735921 S8 DBS STEREOTX
• 00643169878211: SFW 9735911 STEALTH S8 STEREOTAXY
• 00643169878204: SFW 9735910 STEALTH S8 DBS
• 00643169865341: SW APP 9735762 STEALTH S8 APP
• 00643169838987: SFW KIT 9735739 STEALTH S8 STEREOTX
• 00643169838970: SFW KIT 9735738 STEALTH S8 CRN DBS
• 00643169838963: SW KIT 9735737 STEALTH S8 CRANIAL
• 00763000125295: SFW 9735762 APP STEALTH S8 APPLICATION
• 00763000125004: SFW KIT 9735739 STEALTH S8 STEREOTX
• 00763000124991: SFW KIT 9735738 STEALTH S8 CRN DBS
• 00763000117009: SFW KIT 9735737 STEALTH S8 CRANIAL
• 00763000116996: SFW KIT 9735736 STEALTH S8 ENT
• 00763000075309: SFW KIT 9735736 STEALTH S8 ENT
• 00763000075224: SFW KIT 9735921 S8 DBS STEREOTX
• 00763000075170: SFW KIT 9735916 S8 CRANIAL PLAN STATION
• 00763000075132: SFW KIT 9735739 STEALTH S8 STEREOTX
• 00763000075125: SFW KIT 9735738 STEALTH S8 CRN DBS
• 00763000075118: SFW KIT 9735736 STEALTH S8 ENT EU-SW
• 00763000075101: SFW KIT 9735736 STEALTH S8 ENT EU-SE
• 00763000075095: SFW KIT 9735736 STEALTH S8 ENT EU-SC
• 00763000075088: SFW KIT 9735736 STEALTH S8 ENT EU-SD
• 00763000075071: SFW KIT 9735736 STEALTH S8 ENT EU-NW
• 00763000075064: SFW KIT 9735736 STEALTH S8 ENT EU-E
• 00763000074951: SFW KIT 9735737 STEALTH S8 CRANIAL EU-SE
• 00763000070625: SFW KIT 9735737 STEALTH S8 CRANIAL
• 00763000238810: SFW KIT 9735736 STEALTH S8 ENT
• 00763000234812: SFW KIT 9735737 STEALTH S8 CRANIAL EU-SW
• 00763000238650: SFW KIT 9735739 STEALTH S8 STEREOTX
• 00763000238902: SFW KIT 9735738 STEALTH S8 CRN DBS
• 00763000234867: SFW 9735762 APP STEALTH S8 APPLICATION
• 00763000234799: SFW KIT 9735737 STEALTH S8 CRANIAL
• 00763000378424: SFW KIT 9735738 STEALTH S8 CRN DBS
• 00763000374167: SFW KIT 9735737 STEALTH S8 CRANIAL
• 00763000373580: SFW KIT 9735739 STEALTH S8 STEREOTX
• 00763000368494: SFW 9735762 APP STEALTH S8 APPLICATION
• 00763000376215: SFW KIT 9735736 STEALTH S8 ENT