Solera

GUDID 00643169545793

DILATOR NAV2018K SOLERA AWLTIPTAP LARGE

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00643169545793
• NIH Device Record Key: 98326e35-8bc0-447e-9263-f38749a6db4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solera
• Version Model Number: NAV2018K
• 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	00643169545793 [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

[00643169545793]

Moist Heat or Steam Sterilization

[00643169545793]

Moist Heat or Steam Sterilization

[00643169545793]

Moist Heat or Steam Sterilization

[00643169545793]

Moist Heat or Steam Sterilization

[00643169545793]

Moist Heat or Steam Sterilization

[00643169545793]

Moist Heat or Steam Sterilization

[00643169545793]

Moist Heat or Steam Sterilization

[00643169545793]

Moist Heat or Steam Sterilization

[00643169545793]

Moist Heat or Steam Sterilization

[00643169545793]

Moist Heat or Steam Sterilization

[00643169545793]

Moist Heat or Steam Sterilization

[00643169545793]

Moist Heat or Steam Sterilization

[00643169545793]

Moist Heat or Steam Sterilization

[00643169545793]

Moist Heat or Steam Sterilization

[00643169545793]

Moist Heat or Steam Sterilization

[00643169545793]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-30

On-Brand Devices [Solera]

• 00643169545861: DRIVER NAV2025K SOLERA 4.75 REDUCT MAS
• 00643169545854: DRIVER NAV2024K SOLERA 4.75 STANDARD MAS
• 00643169545847: DRIVER NAV2023K SOLERA 4.75 MAS LG2
• 00643169545830: DRIVER NAV2022K SOLERA 5.5/6 FAS/SAS LG2
• 00643169545823: DRIVER NAV2021K SOLERA 5.5/6 FAS/SAS LG
• 00643169545816: DRIVER NAV2020K SOLERA 5.5/6 MAS LG2
• 00643169545809: DRIVER NAV2019K SOLERA 5.5/6 MAS LG
• 00643169545793: DILATOR NAV2018K SOLERA AWLTIPTAP LARGE
• 00643169545786: DILATOR NAV2017K SOLERA AWLTIPTAP SMALL
• 00643169541054: TAP NAV2016K SOLERA AWLTIPTAP 5.5-6.5MM
• 00643169541047: TAP NAV2015K SOLERA AWLTIPTAP 4.5-5.5MMA^
• 00643169541030: TAP NAV2014K SOLERA AWLTIPTAP 10.5MM
• 00643169541023: TAP NAV2013K SOLERA AWLTIPTAP 10MM
• 00643169541016: TAP NAV2012K SOLERA AWLTIPTAP 9.5MM
• 00643169541009: TAP NAV2011K SOLERA AWLTIPTAP 9MM
• 00643169540996: TAP NAV2010K SOLERA AWLTIPTAP 8.5MM
• 00643169540989: TAP NAV2009K SOLERA AWLTIPTAP 8MM
• 00643169540972: TAP NAV2008K SOLERA AWLTIPTAP 7.5MM
• 00643169540965: TAP NAV2007K SOLERA AWLTIPTAP 7MM
• 00643169540958: TAP NAV2006K SOLERA AWLTIPTAP 6.5MM
• 00643169540941: TAP NAV2005K SOLERA AWLTIPTAP 6MM
• 00643169540934: TAP NAV2004K SOLERA AWLTIPTAP 5.5MM
• 00643169540927: TAP NAV2003K SOLERA AWLTIPTAP 5MM
• 00643169540910: TAP NAV2002K SOLERA AWLTIPTAP 4.5MM
• 00643169540903: TAP NAV2001K SOLERA AWLTIPTAP 4.0 MM