CORI ROB10100

GUDID 00885556809600

CORI KNEE TENSIONER

Smith & Nephew, Inc.

Orthopaedic knee-balance analyser, electrically-powered

• Primary Device ID: 00885556809600
• NIH Device Record Key: 7e8a0397-9b86-4c35-872d-3e0803102935
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORI
• Version Model Number: ROB10100
• Catalog Number: ROB10100
• 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: false
• Lot Batch: false
• Serial Number: true
• 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)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	00885556809600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221224

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00885556809600]

Moist Heat or Steam Sterilization

[00885556809600]

Moist Heat or Steam Sterilization

[00885556809600]

Moist Heat or Steam Sterilization

[00885556809600]

Moist Heat or Steam Sterilization

[00885556809600]

Moist Heat or Steam Sterilization

[00885556809600]

Moist Heat or Steam Sterilization

[00885556809600]

Moist Heat or Steam Sterilization

[00885556809600]

Moist Heat or Steam Sterilization

[00885556809600]

Moist Heat or Steam Sterilization

[00885556809600]

Moist Heat or Steam Sterilization

[00885556809600]

Moist Heat or Steam Sterilization

[00885556809600]

Moist Heat or Steam Sterilization

[00885556809600]

Moist Heat or Steam Sterilization

[00885556809600]

Moist Heat or Steam Sterilization

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