PoleStar®

GUDID 00613994209658

FLEXCOIL 9733063 BAND D/E ADJUSTBLE 10PK

MEDTRONIC NAVIGATION, INC.

Extremity MRI system, permanent magnet Extremity MRI system, permanent magnet

• Primary Device ID: 00613994209658
• NIH Device Record Key: 0f78051f-1b62-4586-abcb-565f867f78a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PoleStar®
• Version Model Number: 9733063
• Company DUNS: 835233107
• Company Name: MEDTRONIC NAVIGATION, INC.
• Device Count: 10
• 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: true
• 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	00613994209658 [Primary]
GS1	70613994209657 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032541

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

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: 2016-05-27

On-Brand Devices [PoleStar®]

• 00613994209658: FLEXCOIL 9733063 BAND D/E ADJUSTBLE 10PK
• 00643169351721: INST SET 9733999 POLESTAR
• 00885074370064: POLESTAR, 9731357, PASSIVE PLANAR-BRONZE
• 00885074361529: FRAME, 9731724, DETACH PASSIVE PATIENT