CSR Shoulder System

GUDID 00811596030353

XS Humeral Modular Cut Guide 1

CATALYST ORTHOSCIENCE INC.

Osteotomy guide Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable
Primary Device ID00811596030353
NIH Device Record Key43b6d349-bd5a-4129-8953-49cb988683c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameCSR Shoulder System
Version Model Number1226-5036
Company DUNS079702565
Company NameCATALYST ORTHOSCIENCE INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-587-5137
Emailddavison@catalystortho.com
Phone800-587-5137
Emailddavison@catalystortho.com
Phone800-587-5137
Emailddavison@catalystortho.com
Phone800-587-5137
Emailddavison@catalystortho.com
Phone800-587-5137
Emailddavison@catalystortho.com
Phone800-587-5137
Emailddavison@catalystortho.com
Phone800-587-5137
Emailddavison@catalystortho.com
Phone800-587-5137
Emailddavison@catalystortho.com
Phone800-587-5137
Emailddavison@catalystortho.com
Phone800-587-5137
Emailddavison@catalystortho.com
Phone800-587-5137
Emailddavison@catalystortho.com
Phone800-587-5137
Emailddavison@catalystortho.com
Phone800-587-5137
Emailddavison@catalystortho.com
Phone800-587-5137
Emailddavison@catalystortho.com
Phone800-587-5137
Emailddavison@catalystortho.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 AgencyDevice ID
GS100811596030353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00811596030353]

Moist Heat or Steam Sterilization


[00811596030353]

Moist Heat or Steam Sterilization


[00811596030353]

Moist Heat or Steam Sterilization


[00811596030353]

Moist Heat or Steam Sterilization


[00811596030353]

Moist Heat or Steam Sterilization


[00811596030353]

Moist Heat or Steam Sterilization


[00811596030353]

Moist Heat or Steam Sterilization


[00811596030353]

Moist Heat or Steam Sterilization


[00811596030353]

Moist Heat or Steam Sterilization


[00811596030353]

Moist Heat or Steam Sterilization


[00811596030353]

Moist Heat or Steam Sterilization


[00811596030353]

Moist Heat or Steam Sterilization


[00811596030353]

Moist Heat or Steam Sterilization


[00811596030353]

Moist Heat or Steam Sterilization


[00811596030353]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-23
Device Publish Date2020-01-15

On-Brand Devices [CSR Shoulder System]

00811596030087Press-Fit Humeral Size I
00811596030070Press-Fit Humeral Size H
00811596030063Press-Fit Humeral Implant Size G
00811596030056Press-Fit Humeral Implant Size E
00811596030049Press-Fit Humeral Size F
00811596030032Press-Fit Humeral Implant Size D
00811596030025Press-Fit Humeral Implant Size C
00811596030018Press Fit Humeral Implant Size A
00811596030001Press-Fit Humeral Implant Size B
008115960301623-Peg Augment Trial - 10°, Size: Large
008115960301553-Peg Augment Trial - 10°, Size: Medium
008115960301483-Peg Augment Trial - 10°, Size: Small
00811596030131Augmented 3-Peg Glenoid Implant - 10°, Size: Large
00811596030124Augmented 3-Peg Glenoid Implant - 10°, Size: Medium
00811596030117Augmented 3-Peg Glenoid Implant - 10°, Size: Small
00811596030353XS Humeral Modular Cut Guide 1
00811596030346XXS Angled Reamer
00811596030339XS Angled Reamer
00811596030193Small Humeral Cover
008115960301795.75mm Drill Guide Locking Pin
00851388006975Sterile Humeral Cut Guide Fixation Kit
00811596031404Monolithic Cut Guide I

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.