CORNERSTONE® PSR System

GUDID 00885074177717

INSERTER 875-782 CSTONE II DUAL PIVOT

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00885074177717
• NIH Device Record Key: c23e7657-4f42-47be-9f5e-6d170cec0056
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORNERSTONE® PSR System
• Version Model Number: 875-782
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885074177717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111264

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[00885074177717]

Moist Heat or Steam Sterilization

[00885074177717]

Moist Heat or Steam Sterilization

[00885074177717]

Moist Heat or Steam Sterilization

[00885074177717]

Moist Heat or Steam Sterilization

[00885074177717]

Moist Heat or Steam Sterilization

[00885074177717]

Moist Heat or Steam Sterilization

[00885074177717]

Moist Heat or Steam Sterilization

[00885074177717]

Moist Heat or Steam Sterilization

[00885074177717]

Moist Heat or Steam Sterilization

[00885074177717]

Moist Heat or Steam Sterilization

[00885074177717]

Moist Heat or Steam Sterilization

[00885074177717]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2015-08-19

On-Brand Devices [CORNERSTONE® PSR System]

• 00885074354323: INSERTER 6279002 PSR ENDCAP THREADED
• 00885074177717: INSERTER 875-782 CSTONE II DUAL PIVOT
• 00885074372006: CORNERSTONE PSR OUTER CASE