Vertex Select

GUDID 00643169713352

BIT NAV2075K VRT STERILE DRILL BIT 2.4MM

MEDTRONIC SOFAMOR DANEK, INC.

Fluted surgical drill bit, single-use, sterile

• Primary Device ID: 00643169713352
• NIH Device Record Key: 4b6ff976-537e-4adb-8fdb-a716d7fc2276
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vertex Select
• Version Model Number: NAV2075K
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, 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
• 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 Dimensions

• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter
• Outer Diameter: 2.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169713352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143628

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2017-01-19

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00763000673857 - n/a: 2024-11-15 INSTRUMENT 8670007 SXTNT TORCR PRBE SLVE
• 00763000675059 - n/a: 2024-11-15 HANDLE 8239002 COUNTER TORQUE HANDLE
• 00763000864590 - n/a: 2024-11-15 TAMP 9359003 SMALL BONE TAMP
• 00763000864620 - n/a: 2024-11-15 TAMP 9359904 LARGE BONE TAMP
• 00763000864903 - n/a: 2024-11-15 INSTRUMENT 905-820 MESH ACTOR STRAIGHT
• 00763000864910 - n/a: 2024-11-15 INSTRUMENT 905-825 ANGLED MESH IMPACTOR
• 00763000864934 - n/a: 2024-11-15 INSTRUMENT 905-880 END RING DRVR
• 00763000877910 - n/a: 2024-11-15 DRIVER 7730906 MINI-PLATE ANGLED DRIVER