FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867061200
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-9502-42RCPC
Catalog number
AR-9502-42RCPC
Device description
UNIVERS REVS CUP,42/+ 2MM RT OFFSET CTD
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE
PHXshoulder prosthesis, reverse configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867061200PrimaryGS10
M150AR950242RCPC2SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867061200008888670612008888670612000888867061200

GMDN Terms#

Term, Definition table
TermDefinition
Total reverse shoulder prosthesisA sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the joint particularly in patients with chronic, longstanding rotator cuff muscle tears, arthritis, and/or humeral fractures unsuccessfully treated by previous surgery. The device reverses normal anatomy so that the head portion of the joint is attached to the scapula and the socket portion is attached to the humerus. It typically includes a humeral stem and glenosphere (head) with body and cup components. The device may include screws for implantation and may be implanted with or without bone cement.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
131747628
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867023987Arthrex®AR-1934BFT-2AR-1934BFT-22019-03-09
00888867050372Arthrex®AR-8934BNFAR-8934BNF2018-12-13
00888867290778Arthrex®AR-1938PSSAR-1938PSS2018-04-19
00888867348691Arthrex®AR-1934BCT-2AR-1934BCT-22022-07-11
00888867375116Arthrex®AR-8934BCSTAR-8934BCST2021-05-24
00888867375123Arthrex®AR-8934BCST-2AR-8934BCST-22021-05-24
00888867443624Arthrex®AR-2424PHSAR-2424PHS2024-01-25
00888867443631Arthrex®AR-2424PHS-1AR-2424PHS-12024-01-25
00888867384811Arthrex®AR-8934BCST-1AR-8934BCST-12021-05-24
00888867384828Arthrex®AR-8934BCST-2-1AR-8934BCST-2-12021-05-24
00888867285057Arthrex®AR-1934PF-24-1AR-1934PF-24-12020-12-15
00888867293830Arthrex®AR-1938PSS-1AR-1938PSS-12018-10-29
00888867335035Arthrex®AR-2923BCSAR-2923BCS2020-03-16
00888867088306Arthrex®AR-13110R-02AR-13110R-022017-02-15
00888867046641Arthrex®AR-8825BAR-8825B2017-02-15
00888867046672Arthrex®AR-8825PAR-8825P2017-02-15
00888867131491Arthrex®AR-8923BCAR-8923BC2017-02-15
00888867022874Arthrex®AR-1922BCAR-1922BC2017-02-15
00888867022959Arthrex®AR-1922PSAR-1922PS2017-02-15
00888867023017Arthrex®AR-1923BCAR-1923BC2017-02-15

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Primary DI, Brand, Company table
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