PRESTIGE LP™

GUDID 00613994714831

INNER SHAFT 6973050 5MM INSERTER US

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic graft inserter

• Primary Device ID: 00613994714831
• NIH Device Record Key: 2602f3db-bf5a-41cf-8b4c-593765e640ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRESTIGE LP™
• Version Model Number: 6973050
• 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: 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

Device Dimensions

• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994714831 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P090029

FDA Product Code

• MJO: PROSTHESIS, INTERVERTEBRAL DISC

Sterilization

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

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

Moist Heat or Steam Sterilization

[00613994714831]

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: 2016-09-30

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