Navigated Infinity ™ Instruments

GUDID 00643169725447

TAP NAV3606040 4.0MM NAVIGATED

MEDTRONIC SOFAMOR DANEK, INC.

Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable

• Primary Device ID: 00643169725447
• NIH Device Record Key: 2c973c6c-bce1-4c17-9b02-f1b716cfc32a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigated Infinity ™ Instruments
• Version Model Number: NAV3606040
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00643169725447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173338

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00643169725447]

Moist Heat or Steam Sterilization

[00643169725447]

Moist Heat or Steam Sterilization

[00643169725447]

Moist Heat or Steam Sterilization

[00643169725447]

Moist Heat or Steam Sterilization

[00643169725447]

Moist Heat or Steam Sterilization

[00643169725447]

Moist Heat or Steam Sterilization

[00643169725447]

Moist Heat or Steam Sterilization

[00643169725447]

Moist Heat or Steam Sterilization

[00643169725447]

Moist Heat or Steam Sterilization

[00643169725447]

Moist Heat or Steam Sterilization

[00643169725447]

Moist Heat or Steam Sterilization

[00643169725447]

Moist Heat or Steam Sterilization

[00643169725447]

Moist Heat or Steam Sterilization

[00643169725447]

Moist Heat or Steam Sterilization

[00643169725447]

Moist Heat or Steam Sterilization

[00643169725447]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-07
• Device Publish Date: 2023-07-29

On-Brand Devices [Navigated Infinity ™ Instruments]

• 00643169862494: DRILL NAVNS3606010 2.4MM NAV NONSTERILE
• 00643169862470: TAP NAV3606055 5.0MM NAVIGATED
• 00643169839663: MODULE 3607037 NAVIGATED INSTRUMENT
• 00643169778344: GUIDE NAV3606006 DT NAVIGATION
• 00643169725423: TAP NAV3606030 3.0MM NAVIGATED
• 00643169725461: SCREWDRIVER NAV3606195 NAVIGATD THREADED
• 00643169725454: TAP NAV3606045 4.5MM NAVIGATED
• 00643169725447: TAP NAV3606040 4.0MM NAVIGATED
• 00643169725430: TAP NAV3606035 3.5MM NAVIGATED