CSR Shoulder System

GUDID 00811596030346

XXS Angled Reamer

CATALYST ORTHOSCIENCE INC.

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00811596030346
• NIH Device Record Key: 5b3ff1bd-3a25-495a-a253-b3c826a70a90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CSR Shoulder System
• Version Model Number: 1226-5030-005
• 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: 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: 800-587-5137
• Email: ddavison@catalystortho.com
• Phone: 800-587-5137
• Email: ddavison@catalystortho.com
• Phone: 800-587-5137
• Email: ddavison@catalystortho.com
• Phone: 800-587-5137
• Email: ddavison@catalystortho.com
• Phone: 800-587-5137
• Email: ddavison@catalystortho.com
• Phone: 800-587-5137
• Email: ddavison@catalystortho.com
• Phone: 800-587-5137
• Email: ddavison@catalystortho.com
• Phone: 800-587-5137
• Email: ddavison@catalystortho.com
• Phone: 800-587-5137
• Email: ddavison@catalystortho.com
• Phone: 800-587-5137
• Email: ddavison@catalystortho.com
• Phone: 800-587-5137
• Email: ddavison@catalystortho.com
• Phone: 800-587-5137
• Email: ddavison@catalystortho.com
• Phone: 800-587-5137
• Email: ddavison@catalystortho.com
• Phone: 800-587-5137
• Email: ddavison@catalystortho.com
• Phone: 800-587-5137
• Email: ddavison@catalystortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811596030346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152825

FDA Product Code

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

Sterilization

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

[00811596030346]

Moist Heat or Steam Sterilization

[00811596030346]

Moist Heat or Steam Sterilization

[00811596030346]

Moist Heat or Steam Sterilization

[00811596030346]

Moist Heat or Steam Sterilization

[00811596030346]

Moist Heat or Steam Sterilization

[00811596030346]

Moist Heat or Steam Sterilization

[00811596030346]

Moist Heat or Steam Sterilization

[00811596030346]

Moist Heat or Steam Sterilization

[00811596030346]

Moist Heat or Steam Sterilization

[00811596030346]

Moist Heat or Steam Sterilization

[00811596030346]

Moist Heat or Steam Sterilization

[00811596030346]

Moist Heat or Steam Sterilization

[00811596030346]

Moist Heat or Steam Sterilization

[00811596030346]

Moist Heat or Steam Sterilization

[00811596030346]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-28
• Device Publish Date: 2019-11-20

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