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.

• 00763000857349 - VERTE-STACK® Spinal System: 2025-01-07 SPACER 6272044 PSR STRUT 44 X 14 X 11MM
• 00763000857493 - VERTE-STACK® Spinal System: 2025-01-07 SPACER 6287141 PSR LAT PORTS 11X14X11
• 00763000857530 - VERTE-STACK® Spinal System: 2025-01-07 SPACER 6287641 PSR LAT PORTS 6X14X11
• 00763000650254 - CD Horizon™ ModuLeX™ FNS Screw Set: 2025-01-06 SHANK 55900524530 CANN OG FNS 4.5X30 TI
• 00763000650261 - CD Horizon™ ModuLeX™ FNS Screw Set: 2025-01-06 SHANK 55900524535 CANN OG FNS 4.5X35 TI
• 00763000650278 - CD Horizon™ ModuLeX™ FNS Screw Set: 2025-01-06 SHANK 55900524540 CANN OG FNS 4.5X40 TI
• 00763000650285 - CD Horizon™ ModuLeX™ FNS Screw Set: 2025-01-06 SHANK 55900524545 CANN OG FNS 4.5X45 TI
• 00763000650292 - CD Horizon™ ModuLeX™ FNS Screw Set: 2025-01-06 SHANK 55900524550 CANN OG FNS 4.5X50 TI