Polestar

GUDID 00613994316264

SET 9733487 INTEGRATED SKULL PINS

MEDTRONIC NAVIGATION, INC.

Stereotactic radiosurgical invasive head frame

• Primary Device ID: 00613994316264
• NIH Device Record Key: 780a89a8-f5d9-4356-802c-7fcfe0be3054
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polestar
• Version Model Number: 9733487
• 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: true
• 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	00613994316264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032541

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

Sterilization

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

[00613994316264]

Moist Heat or Steam Sterilization

[00613994316264]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-01

On-Brand Devices [Polestar]

• 00613994532053: ARM 9734020 PRF V2
• 00613994505002: HEADREST 9733988 PEDIATRIC HORSESHOE
• 00613994316264: SET 9733487 INTEGRATED SKULL PINS