StealthStation® Cranial

GUDID 00643169625570

SW KIT 9735586 STEALTHSTATION CRANIAL

MEDTRONIC NAVIGATION, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00643169625570
• NIH Device Record Key: 4c3d6f4b-3505-4033-907e-191e246834ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StealthStation® Cranial
• Version Model Number: 9735586
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169625570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153660

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-14

On-Brand Devices [StealthStation® Cranial]

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