Navigated Infinity ™ Instruments

GUDID 00643169725430

TAP NAV3606035 3.5MM NAVIGATED

MEDTRONIC SOFAMOR DANEK, INC.

Bone tap, reusable

• Primary Device ID: 00643169725430
• NIH Device Record Key: 2c999629-547b-4e9d-b80f-6d205eebef88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigated Infinity ™ Instruments
• Version Model Number: NAV3606035
• 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	00643169725430 [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

[00643169725430]

Moist Heat or Steam Sterilization

[00643169725430]

Moist Heat or Steam Sterilization

[00643169725430]

Moist Heat or Steam Sterilization

[00643169725430]

Moist Heat or Steam Sterilization

[00643169725430]

Moist Heat or Steam Sterilization

[00643169725430]

Moist Heat or Steam Sterilization

[00643169725430]

Moist Heat or Steam Sterilization

[00643169725430]

Moist Heat or Steam Sterilization

[00643169725430]

Moist Heat or Steam Sterilization

[00643169725430]

Moist Heat or Steam Sterilization

[00643169725430]

Moist Heat or Steam Sterilization

[00643169725430]

Moist Heat or Steam Sterilization

[00643169725430]

Moist Heat or Steam Sterilization

[00643169725430]

Moist Heat or Steam Sterilization

[00643169725430]

Moist Heat or Steam Sterilization

[00643169725430]

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