FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867418646
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-9096R-12-32
Catalog number
AR-9096R-12-32
Device description
Retrograde Femoral Nail, 12mm x 32cm
Published
2024-01-21
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
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867418646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867418646008888674186468888674186460888867418646

GMDN Terms#

Term, Definition table
TermDefinition
Arthrodesis nail, fixed-lengthA rod of fixed-length (i.e., not intended for distraction) intended to be implanted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] for the purpose of joint fusion or arthrodesis; it is not dedicated to femur or tibia implantation. The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. This is a single-use device.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898624869669NEONAIL Neoortho Produtos Ortopédicos S/A.HSB2015-10-21
07898624869140NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869157NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869164NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869171NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869188NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869195NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869201NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869218NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869225NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869232NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869249NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869256NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869263NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869270NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869287NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869294NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869300NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869317NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869331NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869348NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869355NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869362NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869379NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869386NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869393NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869409NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869416NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869423NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869430NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06