Catalyst CSR Shoulder System

GUDID 00851388006302

Glenoid Sizing Guide Assembly, Small

CATALYST ORTHOSCIENCE INC.

Shoulder glenoid fossa prosthesis trial

• Primary Device ID: 00851388006302
• NIH Device Record Key: 23a7c3f3-1c73-437e-ad87-1e243635adb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Catalyst CSR Shoulder System
• Version Model Number: 1226-5018-001
• 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: sherrington@catalystortho.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, moisture, insects and extremes in temperature and humidity.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851388006302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152825

FDA Product Code

• KWT: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

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

[00851388006302]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-26

On-Brand Devices [Catalyst CSR Shoulder System]

• 00851388006944: Full Instrument Tray
• 00851388006890: 3-Peg Sizing Template, Large
• 00851388006883: 3-peg Sizing Template, Medium
• 00851388006876: 3-Peg Sizing Template, Small
• 00851388006821: 3-Peg Glenoid Trial, Large
• 00851388006814: 3-Peg Glenoid Trial, Medium
• 00851388006807: 3-Peg Glenoid Trial, Small
• 00851388006791: 3-Peg Glenoid Implant, Large
• 00851388006784: 3-Peg Glenoid Implant, Medium
• 00851388006777: 3-Peg Glenoid Implant, Small
• 00851388006746: Humeral Implant, Size I
• 00851388006739: Humeral Implant, Size H
• 00851388006708: Full Instrument Tray
• 00851388006692: Full Instrument Tray
• 00851388006364: Full Instrument Tray
• 00851388006357: Humeral Modular Cut Guide Bottom Assembly
• 00851388006340: Humeral Modular Cut Guide Top Assembly
• 00851388006333: Humeral Modular Cut Guide 1, Assembly
• 00851388006326: Glenoid Sizing Guide Assembly, Large
• 00851388006319: Glenoid Sizing Guide Assembly, Medium
• 00851388006302: Glenoid Sizing Guide Assembly, Small
• 00851388006296: Humeral Trial, Size G
• 00851388006289: Humeral Trial, Size F
• 00851388006272: Humeral Trial, Size E
• 00851388006265: Humeral Trial, Size D
• 00851388006258: Humeral Trial, Size C
• 00851388006241: Humeral Trial, Size B
• 00851388006234: Humeral Trial, Size A
• 00851388006227: Glenoid Trial, Right, Large
• 00851388006210: Glenoid Trial, Right, Medium
• 00851388006203: Glenoid Trial, Right, Small
• 00851388006197: Glenoid Trial, Left, Large
• 00851388006180: Glenoid Trial, Left, Medium
• 00851388006173: Glenoid Trial, Left, Small
• 00851388006166: Humeral Cover
• 00851388006159: Lid
• 00851388006142: Inner Tray
• 00851388006135: Outer Tray
• 00851388006128: Humeral Implant, Size G
• 00851388006111: Humeral Implant, Size F
• 00851388006104: Humeral Implant, Size E
• 00851388006098: Humeral Implant, Size D
• 00851388006081: Humeral Implant, Size C
• 00851388006074: Humeral Implant, Size B
• 00851388006067: Humeral Implant, Size A
• 00851388006050: Glenoid Implant, Right, Large
• 00851388006043: Glenoid Implant, Right, Medium
• 00851388006036: Glenoid Implant, Right, Small
• 00851388006029: Glenoid Implant, Left, Large
• 00851388006012: Glenoid Implant, Left, Small