R1 Reverse Shoulder System

GUDID 00811596030971

Poly Trial 40mm +4mm

CATALYST ORTHOSCIENCE INC.

Shoulder reverse/standard adaptor prosthesis trial

Primary Device ID	00811596030971
NIH Device Record Key	cddacca0-d8b5-425c-80f4-d43586689741
Commercial Distribution Status	In Commercial Distribution
Brand Name	R1 Reverse Shoulder System
Version Model Number	1230-4213-002
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	info@catalystortho.com
Phone	800-587-5137
Email	info@catalystortho.com
Phone	800-587-5137
Email	info@catalystortho.com
Phone	800-587-5137
Email	info@catalystortho.com
Phone	800-587-5137
Email	info@catalystortho.com
Phone	800-587-5137
Email	info@catalystortho.com
Phone	800-587-5137
Email	info@catalystortho.com
Phone	800-587-5137
Email	info@catalystortho.com
Phone	800-587-5137
Email	info@catalystortho.com
Phone	800-587-5137
Email	info@catalystortho.com
Phone	800-587-5137
Email	info@catalystortho.com
Phone	800-587-5137
Email	info@catalystortho.com
Phone	800-587-5137
Email	info@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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811596030971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K202611

FDA Product Code

PHX	Shoulder Prosthesis, Reverse Configuration