FDA.reportPublic FDA data

Catalyst CSR Shoulder System

Primary DI
00851388006708
Brand
Catalyst CSR Shoulder System
Company
CATALYST ORTHOSCIENCE INC.
Model
1226-9002
Device description
Full Instrument Tray
Published
2017-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
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
00851388006708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851388006708008513880067088513880067080851388006708

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811596031404CSR Shoulder System1226-41342021-04-16
00811596030902R1 Reverse Shoulder System1230-42632021-03-03
00811596030919R1 Reverse Shoulder System1230-42562021-03-03
00811596030995R1 Reverse Shoulder System1230-42142021-03-03
00811596031008R1 Reverse Shoulder System1230-52062021-03-03
00811596031015R1 Reverse Shoulder System1230-42172021-03-03
00811596031022R1 Reverse Shoulder System1230-42552021-03-03
00811596031039R1 Reverse Shoulder System1230-42812021-03-03
00811596031046R1 Reverse Shoulder System1230-52042021-03-03
00811596031053R1 Reverse Shoulder System1230-52052021-03-03
00811596031060R1 Reverse Shoulder System1230-52022021-03-03
00811596031077R1 Reverse Shoulder System1230-52112021-03-03
00811596031084R1 Reverse Shoulder System1230-52072021-03-03
00811596031091R1 Reverse Shoulder System1230-52102021-03-03
00811596031107R1 Reverse Shoulder System1230-42222021-03-03
00811596031114R1 Reverse Shoulder System1230-42642021-03-03
00811596031121R1 Reverse Shoulder System1230-42272021-03-03
00811596031138R1 Reverse Shoulder System1230-42262021-03-03
00811596031206R1 Reverse Shoulder System1230-42432021-03-03
00811596031213R1 Reverse Shoulder System1230-42532021-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWT2026-05-28
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.HSD2026-05-28
07613327668889Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
07613327668902Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
07613327668919Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
07613327668896Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
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