FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867229693
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-9548-21RCAT
Catalog number
AR-9548-21RCAT
Device description
Revers Trial CA Head, 48/21
Published
2017-02-15
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867229693PrimaryGS10
M150AR954821RCAT0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867229693008888672296938888672296930888867229693

GMDN Terms#

Term, Definition table
TermDefinition
Reverse shoulder head prosthesis trialA copy of a final reverse shoulder prosthesis head 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 hemisphere-shaped (glenosphere) and typically made of metal and/or 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

Regulatory Flags#

DUNS number
131747628
Device count
1
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
00888867614956Arthrex®AR-S8457EXCAR-S8457EXC2026-05-25
00888867531949Arthrex®AR-8827H-22SAR-8827H-22S2026-03-16
00888867531970Arthrex®AR-8827H-28SAR-8827H-28S2026-03-16
00888867531987Arthrex®AR-8827H-30SAR-8827H-30S2026-03-16
00888867532014Arthrex®AR-8827H-36SAR-8827H-36S2026-03-16
00888867134874Arthrex®AR-9104-04AR-9104-042017-02-15
00888867336506Arthrex®AR-1593-4AR-1593-42019-12-13
00888867336520Arthrex®AR-1593DAR-1593D2019-12-13
00888867310209Arthrex®AR-4158TAR-4158T2019-11-15
00888867340183Arthrex®AR-D8400EXAR-D8400EX2019-10-06
00888867504288Arthrex®AR-9953AR-05AR-9953AR-052026-05-21
00888867504295Arthrex®AR-9953AR-03AR-9953AR-032026-05-21
00888867504318Arthrex®AR-9953AR-07AR-9953AR-072026-05-21
00888867504356Arthrex®AR-9953AR-09AR-9953AR-092026-05-21
00888867504363Arthrex®AR-9953AR-11AR-9953AR-112026-05-21
00888867504387Arthrex®AR-9953AR-13AR-9953AR-132026-05-21
00888867504394Arthrex®AR-9953AL-13AR-9953AL-132026-05-21
00888867504400Arthrex®AR-9953AR-15AR-9953AR-152026-05-21
00888867504417Arthrex®AR-9953AL-15AR-9953AL-152026-05-21
00888867504424Arthrex®AR-9953AR-03SAR-9953AR-03S2026-05-21

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Primary DI, Brand, Company table
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08033390121880SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121897SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121910SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121958SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390108065SMR STEMLESSLIMACORPORATE SPAPHX2022-03-17
08033390134392SMR ShoulderLIMACORPORATE SPAPHX2021-11-27
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