Midas Rex Clearview™

GUDID 00643169308497

TOOL DC SP12MH30 LGD 12CM PROX 3.0 MH

MEDTRONIC XOMED, INC.

Orthopaedic bur, reusable Orthopaedic bur, reusable

• Primary Device ID: 00643169308497
• NIH Device Record Key: b0b6f913-4e7e-4a51-984f-42c4a5619ff8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Midas Rex Clearview™
• Version Model Number: SP12MH30
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, 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: 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 Dimensions

• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169308497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081277

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-22

On-Brand Devices [Midas Rex Clearview™]

• 00643169308527: TOOL DC SP12MH25 LGD 12CM PROX 2.5 MH
• 00643169308510: TOOL DC SP12MH25T LGD 12CM PROX 2.5 MH3F
• 00643169308503: TOOL DC SP12MH25D LGD 12CM PROX 2.5 MH D
• 00643169308497: TOOL DC SP12MH30 LGD 12CM PROX 3.0 MH
• 00643169308480: TOOL DC SP12MH30D LGD 12CM PROX 3.0 MH D
• 00643169308473: TOOL DC SP12BA30 LGD 12CM PROX 3.0 BALL
• 00643169308466: TOOL DC SP12BA40 LGD 12CM PROX 4.0 BALL
• 00643169308459: TOOL DC SP14MH25 LGD 14CM PROX 2.5 MH
• 00643169308442: TOOL DC SP14MH25T LGD 14CM PROX 2.5 MH3F
• 00643169308435: TOOL DC SP14MH25D LGD 14CM PROX 2.5 MH D
• 00643169308428: TOOL DC SP14MH30 LGD 14CM PROX 3.0 MH
• 00643169308411: TOOL DC SP14MH30T LGD 14CM PROX 3.0 MH3F
• 00643169308404: TOOL DC SP14MH30D LGD 14CM PROX 3.0 MH D
• 00643169308398: TOOL DC SP14BA30 LGD 14CM PROX 3.0 BALL
• 00643169308381: TOOL DC SP14BA40 LGD 14CM PROX 4.0 BALL
• 00643169308374: TOOL DC SD12MH25 LGD 12CM DIST 2.5 MH
• 00643169308367: TOOL DC SD12MH25T LGD 12CM DIST 2.5 MH3F
• 00643169308350: TOOL DC SD12MH25D LGD 12CM DIST 2.5 MH D
• 00643169308343: TOOL DC SD12MH30 LGD 12CM DIST 3.0 MH
• 00643169308336: TOOL DC SD12MH30T LGD 12CM DIST 3.0 MH3F
• 00643169308329: TOOL DC SD12MH30D LGD 12CM DIST 3.0 MH D
• 00643169308312: TOOL DC SD12BA30 LGD 12CM DIST 3.0 BALL
• 00643169308305: TOOL DC SD12BA40 LGD 12CM DIST 4.0 BALL
• 00643169308183: TUBING IRD370 EA IPC LOW PRO IRRIGATION
• 20643169308170: TUBING IRD375 5PK IPC LOW PRO IRRIGATION
• 00643169308152: TOOL DC SP12MH30T LGD 12CM PROX 3.0 MH3F