PRESTIGE LP™

GUDID 00613994493675

DISC 6972650 PRESTIGE

MEDTRONIC SOFAMOR DANEK, INC.

Cervical total disc replacement prosthesis, sterile

• Primary Device ID: 00613994493675
• NIH Device Record Key: 98e40726-261f-4b18-8ae6-3b695c15e715
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRESTIGE LP™
• Version Model Number: 6972650
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: true
• 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
• 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 Dimensions

• Depth: 16 Millimeter
• Depth: 16 Millimeter
• Depth: 16 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter
• Height: 5 Millimeter
• Depth: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994493675 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P090029

FDA Product Code

• MJO: PROSTHESIS, INTERVERTEBRAL DISC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-28

On-Brand Devices [PRESTIGE LP™]

• 00613994714831: INNER SHAFT 6973050 5MM INSERTER US
• 00613994493743: DISC 6972250 PRESTIGE
• 00613994493712: DISC 6972450 PRESTIGE
• 00613994493675: DISC 6972650 PRESTIGE
• 00613994490735: PUNCH 6972425 RAIL
• 00613994490711: PUNCH 6972445 RAIL
• 00613994490476: TRIAL 6973225 IMPLANT
• 00613994490452: TRIAL 6973245 IMPLANT
• 00613994490414: TRIAL 6973265 IMPLANT
• 00613994490346: GUIDE 6972525 CUTTER
• 00613994490322: GUIDE 6972545 CUTTER