FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867439108
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-9523-04-135
Catalog number
AR-9523-04-135
Device description
UNIVERS REVERS SIZE 4/33 STEM TRIAL
Published
2023-08-29
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
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867439108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867439108008888674391088888674391080888867439108

GMDN Terms#

Term, Definition table
TermDefinition
Humeral stem prosthesis trial, reusableA copy of a final humeral stem 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 typically made of metal and/or synthetic polymer. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-934-4404complaints@arthrex.com
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867304598Arthrex®AR-7285AR-72852026-07-08
00888867304604Arthrex®AR-7286AR-72862026-07-08
00888867304789Arthrex®AR-7285-1AR-7285-12026-07-08
00888867304796Arthrex®AR-7286-1AR-7286-12026-07-08
00888867023987Arthrex®AR-1934BFT-2AR-1934BFT-22019-03-09
00888867097216Arthrex®AR-1938PHSAR-1938PHS2017-05-11
00888867157767Arthrex®AR-1588TN-2AR-1588TN-22017-08-15
00888867178649Arthrex®AR-8827L-32SAR-8827L-32S2017-04-07
00888867178694Arthrex®AR-8827L-42SAR-8827L-42S2017-04-07
00888867178731Arthrex®AR-8827L-50SAR-8827L-50S2017-04-07
00888867178748Arthrex®AR-8827L-52SAR-8827L-52S2017-04-07
00888867178755Arthrex®AR-8827L-54SAR-8827L-54S2017-05-11
00888867178762Arthrex®AR-8827L-56SAR-8827L-56S2017-05-11
00888867178779Arthrex®AR-8827L-58SAR-8827L-58S2017-05-11
00888867179455Arthrex®AR-8835-65SAR-8835-65S2017-04-07
00888867179462Arthrex®AR-8835-70SAR-8835-70S2017-04-07
00888867179479Arthrex®AR-8835-75SAR-8835-75S2017-04-07
00888867179486Arthrex®AR-8835-80SAR-8835-80S2017-04-07
00888867196537Arthrex®AR-8943C-07SAR-8943C-07S2017-05-11
00888867196582Arthrex®AR-8943C-12SAR-8943C-12S2017-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286853163TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286853170TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286853187TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286855587TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286855921TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859929TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859943TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859967TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859974TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859981TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286859998TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860000TaperSet Hip SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860123Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860130Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860222Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860444Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860468Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860482Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860505Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860529Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860543Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860567Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860581Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00840286860604Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWT2026-07-09
00889024701281Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701298Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701304Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701311Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701328Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10
00889024701335Identity® Shoulder SystemZimmer, Inc.HWT2026-06-10