Catalyst CSR Shoulder System

Primary DI
00851388006326
Brand
Catalyst CSR Shoulder System
Company
CATALYST ORTHOSCIENCE INC.
Model
1226-5018-003
Device description
Glenoid Sizing Guide Assembly, Large
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152825000Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC2016-05-11KWT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851388006326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851388006326008513880063268513880063260851388006326

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder glenoid fossa prosthesis trialA copy of a final shoulder glenoid fossa prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is cup-like in shape and typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Sterile 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-587-5137sherrington@catalystortho.com

Regulatory Flags#

DUNS number
079702565
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811596031886Reverse Shoulder System1230-7523-0011230-7523-0012026-07-17
00811596031893Reverse Shoulder System1230-7523-0021230-7523-0022026-07-17
00811596031909Reverse Shoulder System1230-7524-0011230-7524-0012026-07-17
00811596031916Reverse Shoulder System1230-7524-0021230-7524-0022026-07-17
00811596031923Reverse Shoulder System1230-7513-0031230-7513-0032026-07-17
00811596031930Reverse Shoulder System1230-7514-0031230-7514-0032026-07-17
00811596031947Reverse Shoulder System1230-7525-0011230-7525-0012026-07-17
00811596031954Reverse Shoulder System1230-43131230-43132026-07-17
00811596031961CSR Shoulder System1226-5038-0011226-5038-0012026-07-17
00811596031978CSR Shoulder System1226-5038-0021226-5038-0022026-07-17
00811596031985CSR Shoulder System1226-5038-0031226-5038-0032026-07-17
00811596031992EA Convertible System1231-46051231-46052026-07-17
00811596032005Reverse Shoulder System1230-4224-0031230-4224-0032026-07-17
00811596032012Reverse Shoulder System1230-4225-0031230-4225-0032026-07-17
00811596031695EA Convertible System1231-4601-0011231-4601-0012026-07-14
00811596031701EA Convertible System1231-4601-0021231-4601-0022026-07-14
00811596031718EA Convertible System1231-4601-0031231-4601-0032026-07-14
00811596031725EA Convertible System1231-4601-0041231-4601-0042026-07-14
00811596031732EA Convertible System1231-4601-005231-4601-0052026-07-14
00811596031749EA Convertible System1231-4601-0061231-4601-0062026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811596031961CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031978CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031985CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00889024707047Signature ONE Software PackageOrthosoft IncKWT2026-07-10
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
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