Catalyst CSR Shoulder System

GUDID 00851388006340

Humeral Modular Cut Guide Top Assembly

CATALYST ORTHOSCIENCE INC.

Osteotomy guide

Primary Device ID	00851388006340
NIH Device Record Key	9cc36d2b-f5d1-415d-afc7-c162b9d3945b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Catalyst CSR Shoulder System
Version Model Number	1226-5026
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
Phone	800-587-5137
Email	sherrington@catalystortho.com
Phone	800-587-5137
Email	sherrington@catalystortho.com
Phone	800-587-5137
Email	sherrington@catalystortho.com
Phone	800-587-5137
Email	sherrington@catalystortho.com
Phone	800-587-5137
Email	sherrington@catalystortho.com
Phone	800-587-5137
Email	sherrington@catalystortho.com
Phone	800-587-5137
Email	sherrington@catalystortho.com
Phone	800-587-5137
Email	sherrington@catalystortho.com
Phone	800-587-5137
Email	sherrington@catalystortho.com
Phone	800-587-5137
Email	sherrington@catalystortho.com
Phone	800-587-5137
Email	sherrington@catalystortho.com
Phone	800-587-5137
Email	sherrington@catalystortho.com
Phone	800-587-5137
Email	sherrington@catalystortho.com
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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	00851388006340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K152825

FDA Product Code

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