Catalyst CSR Shoulder System

GUDID 00851388006005

Glenoid Implant, Left, Medium

CATALYST ORTHOSCIENCE INC.

Shoulder glenoid fossa prosthesis, prefabricated
Primary Device ID00851388006005
NIH Device Record Key7eb4057f-f873-4b50-938c-38abcef44c67
Commercial Distribution StatusIn Commercial Distribution
Brand NameCatalyst CSR Shoulder System
Version Model Number1228-7101-002
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-587-5137
Emailsherrington@catalystortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851388006005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-23
Device Publish Date2016-07-25

On-Brand Devices [Catalyst CSR Shoulder System]

00851388006944Full Instrument Tray
008513880068903-Peg Sizing Template, Large
008513880068833-peg Sizing Template, Medium
008513880068763-Peg Sizing Template, Small
008513880068213-Peg Glenoid Trial, Large
008513880068143-Peg Glenoid Trial, Medium
008513880068073-Peg Glenoid Trial, Small
008513880067913-Peg Glenoid Implant, Large
008513880067843-Peg Glenoid Implant, Medium
008513880067773-Peg Glenoid Implant, Small
00851388006746Humeral Implant, Size I
00851388006739Humeral Implant, Size H
00851388006708Full Instrument Tray
00851388006692Full Instrument Tray
00851388006364Full Instrument Tray
00851388006357Humeral Modular Cut Guide Bottom Assembly
00851388006340Humeral Modular Cut Guide Top Assembly
00851388006333Humeral Modular Cut Guide 1, Assembly
00851388006326Glenoid Sizing Guide Assembly, Large
00851388006319Glenoid Sizing Guide Assembly, Medium
00851388006302Glenoid Sizing Guide Assembly, Small
00851388006296Humeral Trial, Size G
00851388006289Humeral Trial, Size F
00851388006272Humeral Trial, Size E
00851388006265Humeral Trial, Size D
00851388006258Humeral Trial, Size C
00851388006241Humeral Trial, Size B
00851388006234Humeral Trial, Size A
00851388006227Glenoid Trial, Right, Large
00851388006210Glenoid Trial, Right, Medium
00851388006203Glenoid Trial, Right, Small
00851388006197Glenoid Trial, Left, Large
00851388006180Glenoid Trial, Left, Medium
00851388006173Glenoid Trial, Left, Small
00851388006166Humeral Cover
00851388006159Lid
00851388006142Inner Tray
00851388006135Outer Tray
00851388006128Humeral Implant, Size G
00851388006111Humeral Implant, Size F
00851388006104Humeral Implant, Size E
00851388006098Humeral Implant, Size D
00851388006081Humeral Implant, Size C
00851388006074Humeral Implant, Size B
00851388006067Humeral Implant, Size A
00851388006050Glenoid Implant, Right, Large
00851388006043Glenoid Implant, Right, Medium
00851388006036Glenoid Implant, Right, Small
00851388006029Glenoid Implant, Left, Large
00851388006012Glenoid Implant, Left, Small

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