GUDID 00643169693838

DRIVER NAV2024K SOLERA 4.75 STANDARD MAS

MEDTRONIC SOFAMOR DANEK, INC.

Surgical screwdriver, reusable

• Primary Device ID: 00643169693838
• NIH Device Record Key: b4ccf1d0-3f6d-4d9e-9447-90b76818e9b7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: NAV2024K
• 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: 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 Dimensions

• Outer Diameter: 4.75 Millimeter
• Outer Diameter: 4.75 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169693838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140454

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00643169693838]

Moist Heat or Steam Sterilization

[00643169693838]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-05
• Device Publish Date: 2016-08-29

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00643169571839 - RIALTO™ SI FUSION SYSTEM: 2025-05-16 DEVICE 74200001245 THREADED 12X45
• 00763000880101 - n/a: 2025-05-16 INSERTER 7967012 CP
• 00643169500365 - CD HORIZON® Growth Rod Conversion Set: 2025-05-13 CONNECTOR 811212GR 110MM TI 5.5MM ROD S
• 00763000878016 - n/a: 2025-05-13 RASP 6630919 PARALLEL 10MMX15MMX12MM
• 00763000878047 - n/a: 2025-05-13 RASP 6630916 PARALLEL 7MMX15MMX12MM
• 00763000891367 - CD Horizon™ ModuLeX™ Spinal System: 2025-05-13 SHANK 55900608510 ILIAC 8.5X110MM
• 00763000891381 - CD Horizon™ ModuLeX™ Spinal System: 2025-05-13 SHANK 55900608560 ILIAC 8.5X60MM
• 00763000280468 - CENTERPIECE™ Plate Fixation System: 2025-05-12 TRAY 8530107R CENTERPIECE INSTRUMENTS