CSR Shoulder System

GUDID 00811596030070

Press-Fit Humeral Size H

CATALYST ORTHOSCIENCE INC.

Resurfacing humeral head prosthesis

• Primary Device ID: 00811596030070
• NIH Device Record Key: 312fca9e-900c-4b92-b449-2bd301c295a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CSR Shoulder System
• Version Model Number: 1228-7300-008
• Company DUNS: 079702565
• Company Name: CATALYST ORTHOSCIENCE 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: 239-325-9976
• Email: ddavison@catalystortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811596030070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182500

FDA Product Code

• HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-20
• Device Publish Date: 2019-05-10

On-Brand Devices [CSR Shoulder System]

• 00811596030087: Press-Fit Humeral Size I
• 00811596030070: Press-Fit Humeral Size H
• 00811596030063: Press-Fit Humeral Implant Size G
• 00811596030056: Press-Fit Humeral Implant Size E
• 00811596030049: Press-Fit Humeral Size F
• 00811596030032: Press-Fit Humeral Implant Size D
• 00811596030025: Press-Fit Humeral Implant Size C
• 00811596030018: Press Fit Humeral Implant Size A
• 00811596030001: Press-Fit Humeral Implant Size B
• 00811596030162: 3-Peg Augment Trial - 10°, Size: Large
• 00811596030155: 3-Peg Augment Trial - 10°, Size: Medium
• 00811596030148: 3-Peg Augment Trial - 10°, Size: Small
• 00811596030131: Augmented 3-Peg Glenoid Implant - 10°, Size: Large
• 00811596030124: Augmented 3-Peg Glenoid Implant - 10°, Size: Medium
• 00811596030117: Augmented 3-Peg Glenoid Implant - 10°, Size: Small
• 00811596030353: XS Humeral Modular Cut Guide 1
• 00811596030346: XXS Angled Reamer
• 00811596030339: XS Angled Reamer
• 00811596030193: Small Humeral Cover
• 00811596030179: 5.75mm Drill Guide Locking Pin
• 00851388006975: Sterile Humeral Cut Guide Fixation Kit
• 00811596031404: Monolithic Cut Guide I