CORI ROB10101

GUDID 00885556809655

CORI KNEE TENSIONER CARTRIDGE

Smith & Nephew, Inc.

Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter

• Primary Device ID: 00885556809655
• NIH Device Record Key: 9e778c54-83dc-4fc9-90a2-6d4c71bec087
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORI
• Version Model Number: ROB10101
• Catalog Number: ROB10101
• Company DUNS: 045483575
• Company Name: Smith & Nephew, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556809655 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221224

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-07
• Device Publish Date: 2022-12-14

On-Brand Devices [CORI]

• 00885556755068: CORI Starter Kit
• 00885556809686: CORI KNEE TENSIONER TRAY INSERT
• 00885556809655: CORI KNEE TENSIONER CARTRIDGE
• 00885556809600: CORI KNEE TENSIONER