CORIOGRAPH ROB20033

GUDID 00885556924761

CORIOGRAPH Shoulder Pre-Operative Planning and Modeling Services V1.0. Modules in scope: CORIOGRAPH Shoulder Pre-Op Plan CORIOGRAPH Modeler for Shoulder

Smith & Nephew, Inc.

Orthopaedic/craniofacial implantation planning software

• Primary Device ID: 00885556924761
• NIH Device Record Key: 7cb0ff48-26d7-4216-9b8b-159eb85fcd7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORIOGRAPH
• Version Model Number: ROB20033
• Catalog Number: ROB20033
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556924761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250921

FDA Product Code

• PBF: Orthopaedic surgical planning and instrument guides

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-27
• Device Publish Date: 2025-08-19

On-Brand Devices [CORIOGRAPH]

• 00885556917442: CORIOGRAPH PRE-OP PLANNING AND MODELING SERVICE
• 00885556921524: CORIOGRAPH Pre-Operative Planning and Modeling Services V2.0. Modules in scope: CORIOGRAPH Knee
• 00885556924761: CORIOGRAPH Shoulder Pre-Operative Planning and Modeling Services V1.0. Modules in scope: CORIOGR