GUDID 00643169545885

TAPS MODULE NAV2027K LG2NAV TAPS MODULE

MEDTRONIC SOFAMOR DANEK, INC.

Bone tap, reusable

• Primary Device ID: 00643169545885
• NIH Device Record Key: b2165cc3-8c89-48d0-b6ac-bdaacc5b1113
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: NAV2027K
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169545885 [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

[00643169545885]

Moist Heat or Steam Sterilization

[00643169545885]

Moist Heat or Steam Sterilization

[00643169545885]

Moist Heat or Steam Sterilization

[00643169545885]

Moist Heat or Steam Sterilization

[00643169545885]

Moist Heat or Steam Sterilization

[00643169545885]

Moist Heat or Steam Sterilization

[00643169545885]

Moist Heat or Steam Sterilization

[00643169545885]

Moist Heat or Steam Sterilization

[00643169545885]

Moist Heat or Steam Sterilization

[00643169545885]

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: 2016-08-29

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00763000857172 - VERTE-STACK® Spinal System: 2024-12-16 SPACER 6277441 CORNERSTONE PSR 4X14X11MM
• 00763000857387 - VERTE-STACK® Spinal System: 2024-12-16 SPACER 6277006 PSR STRUT 6 X 14 X 11MM
• 00763000868475 - CORNERSTONE® PSR Cervical Fusion System: 2024-12-16 IMPLANT 6284641 PEEK CRV 14X11X6MM
• 00763000878818 - NA: 2024-12-16 INSTRUMENT 803-043 GUIDEWIRE
• 00643169964938 - GRAFTON™ DBM: 2024-12-13 DBM T42275INT 8MMX1CMX10CM 2 EA GRFTON S
• 00763000879549 - Endoskeleton™ TCS Interbody System: 2024-12-09 RONGEUR 5210-1015 TCS RONGEUR
• 00763000879624 - Endoskeleton™ TCS Interbody System: 2024-12-09 EXTRACTOR 5210-1048 TCS BONE SCREW
• 00763000885151 - n/a: 2024-12-09 INSTRUMENT 2900250 SPREADER 6MM