CSR Shoulder System

GUDID 00851388006975

Sterile Humeral Cut Guide Fixation Kit

CATALYST ORTHOSCIENCE INC.

Scalpel, single-use
Primary Device ID00851388006975
NIH Device Record Keyf3ccc98a-aa8b-4d01-91ea-9aae7bb6baaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameCSR Shoulder System
Version Model Number1229-7430
Company DUNS079702565
Company NameCATALYST ORTHOSCIENCE INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100851388006975 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-17
Device Publish Date2020-07-09

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

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