FDA.report

Arthrex®

Primary DI
00888867439092
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-9501-04-135P
Catalog number
AR-9501-04-135P
Device description
UNIVERS REVERS SIZE 4/33 MONOBLOCK STEM
Published
2023-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Product Code Classifications

CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888867439092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867439092008888674390928888674390920888867439092

GMDN Terms

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

Contacts

PhoneEmail
1-800-934-4404complaints@arthrex.com
+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 DIBrandModelCatalogPublished
00888867561687Arthrex®AR-2600FSF-1AR-2600FSF-12026-03-17
00888867561694Arthrex®AR-2600FSF-2AR-2600FSF-22026-03-17
00888867561700Arthrex®AR-2600FSF-3AR-2600FSF-32026-03-17
00888867463363Arthrex®AR-8974-02AR-8974-022026-03-16
00888867519459Arthrex®AR-8974FCAR-8974FC2026-03-16
00888867519473Arthrex®AR-8974FCLAR-8974FCL2026-03-16
00888867519503Arthrex®AR-8974TAR-8974T2026-03-16
00888867519510Arthrex®AR-8974TLAR-8974TL2026-03-16
00888867529038Arthrex®AR-8827H-10AR-8827H-102026-03-16
00888867529045Arthrex®AR-8827H-12AR-8827H-122026-03-16
00888867529052Arthrex®AR-8827H-14AR-8827H-142026-03-16
00888867529069Arthrex®AR-8827H-16AR-8827H-162026-03-16
00888867529076Arthrex®AR-8827H-18AR-8827H-182026-03-16
00888867529083Arthrex®AR-8827H-20AR-8827H-202026-03-16
00888867529090Arthrex®AR-8827H-22AR-8827H-222026-03-16
00888867529106Arthrex®AR-8827H-24AR-8827H-242026-03-16
00888867529113Arthrex®AR-8827H-26AR-8827H-262026-03-16
00888867529120Arthrex®AR-8827H-28AR-8827H-282026-03-16
00888867529137Arthrex®AR-8827H-30AR-8827H-302026-03-16
00888867529144Arthrex®AR-8827H-32AR-8827H-322026-03-16

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