CSR Shoulder System

Basic Information

• Brand Name: CSR Shoulder System
• Primary DI: 00811596030353
• Version / Model: 1226-5036
• Company Name: CATALYST ORTHOSCIENCE INC.
• Labeler DUNS: 079702565
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-15
• Public Version: 2
• Public Version Date: 2020-09-22
• Public Version Status: Update
• Public Device Record Key: 43b6d349-bd5a-4129-8953-49cb988683c5

Device Description

XS Humeral Modular Cut Guide 1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	888.3690	2
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	888.3650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61917	Osteotomy guide, reusable	A surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811596030353	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K152825	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: 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.