FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867140677
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-9502-42
Catalog number
AR-9502-42
Device description
UNIVERS REVERS CUP, 42/ NEUTRAL
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867140677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867140677008888671406778888671406770888867140677

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.

Contacts#

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

Regulatory Flags#

DUNS number
131747628
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661489725463JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEKWS2026-08-03
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-17
05404028001288SurgiCase PlannerMaterialise NVKWS2026-07-16
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031701EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031749EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031657EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031664EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031671EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031688EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00889024707047Signature ONE Software PackageOrthosoft IncKWS2026-07-10
10885862657244EquinoxeExactech, Inc.KWS2026-07-07
10885862657251EquinoxeExactech, Inc.KWS2026-07-07
10885862657268EquinoxeExactech, Inc.KWS2026-07-07
10885862657275EquinoxeExactech, Inc.KWS2026-07-07
10885862657282EquinoxeExactech, Inc.KWS2026-07-07
10885862657299EquinoxeExactech, Inc.KWS2026-07-07
10885862657305EquinoxeExactech, Inc.KWS2026-07-07
10885862657312EquinoxeExactech, Inc.KWS2026-07-07
10885862657329EquinoxeExactech, Inc.KWS2026-07-07
10885862657336EquinoxeExactech, Inc.KWS2026-07-07
10885862657343EquinoxeExactech, Inc.KWS2026-07-07
10885862657350EquinoxeExactech, Inc.KWS2026-07-07
10885862657367EquinoxeExactech, Inc.KWS2026-07-07
10885862657374EquinoxeExactech, Inc.KWS2026-07-07
10885862657381EquinoxeExactech, Inc.KWS2026-07-07
10885862657398EquinoxeExactech, Inc.KWS2026-07-07