CORI ROB10000

GUDID 00885556755068

CORI Starter Kit

Smith & Nephew, Inc.

Robotic surgical system

• Primary Device ID: 00885556755068
• NIH Device Record Key: 40ce926b-ce18-4312-846e-9b0151a20fab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORI
• Version Model Number: ROB10000
• Catalog Number: ROB10000
• Company DUNS: 109903521
• 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: 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)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
• 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
• 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	00885556755068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193120

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

[00885556755068]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-20
• Device Publish Date: 2020-04-10

On-Brand Devices [CORI]

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