R1 Reverse Shoulder System

Primary DI
00811596031145
Brand
R1 Reverse Shoulder System
Company
CATALYST ORTHOSCIENCE INC.
Model
1230-4223-001
Device description
Glenosphere Trial 32mm +4mm
Published
2021-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202611000Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.2021-02-12PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811596031145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811596031145008115960311458115960311450811596031145

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder reverse/standard adaptor prosthesis trialA copy of a final shoulder reverse/standard adaptor prosthesis designed to be used before revision implant surgery to validate the appropriate size of the permanent prosthesis required by the patient, and to ensure its proper orientation and positioning. It is double male taper disc 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
800-587-5137info@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
00811596033460CSR Shoulder System1227-5120-0011227-5120-0012026-09-22
00811596033477CSR Shoulder System1227-5120-0021227-5120-0022026-09-22
00811596033484CSR Shoulder System1227-5120-0031227-5120-0032026-09-22
00811596032524F1x Fracture Stem System1232-7551-0011232-7551-0012026-08-25
00811596032531F1x Fracture Stem System1232-7551-0021232-7551-0022026-08-25
00811596032548F1x Fracture Stem System1232-7551-0031232-7551-0032026-08-25
00811596032555F1x Fracture Stem System1232-7552-0011232-7552-0012026-08-25
00811596032562F1x Fracture Stem System1232-7552-0021232-7552-0022026-08-25
00811596032579F1x Fracture Stem System1232-7552-0031232-7552-0032026-08-25
00811596032586F1x Fracture Stem System1232-50031232-50032026-08-25
00811596032593F1x Fracture Stem System1232-4005-0021232-4005-0022026-08-25
00811596032609F1x Fracture Stem System1232-4005-0031232-4005-0032026-08-25
00811596032616F1x Fracture Stem System1232-4005-0041232-4005-0042026-08-25
00811596032623F1x Fracture Stem System1232-4005-0051232-4005-0052026-08-25
00811596032630F1x Fracture Stem System1232-4005-0061232-4005-0062026-08-25
00811596032647F1x Fracture Stem System1232-4005-0071232-4005-0072026-08-25
00811596032654F1x Fracture Stem System1232-4005-0081232-4005-0082026-08-25
00811596032661F1x Fracture Stem System1232-4005-0091232-4005-0092026-08-25
00811596032678F1x Fracture Stem System1232-4005-0101232-4005-0102026-08-25
00811596032685F1x Fracture Stem System1232-4005-0111232-4005-0112026-08-25

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Primary DI, Brand, Company table
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