FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867358232
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-8735-15
Catalog number
AR-8735-15
Device description
Low Profile Screw, Cortical,3.5x15mm,DRP
Published
2023-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSRUnit, Traction, Hip, Non-Powered, Non-Penetrating
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSRUnit, Traction, Hip, Non-Powered, Non-PenetratingOrthopedic1
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867358232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867358232008888673582328888673582320888867358232

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
00888867473553Arthrex®AR-1288QAI-100AR-1288QAI-1002025-03-18
00888867473560Arthrex®AR-1288QAI-110AR-1288QAI-1102025-03-18
00888867473577Arthrex®AR-1288QAI-80AR-1288QAI-802025-03-18
00888867473584Arthrex®AR-1288QAI-90AR-1288QAI-902025-03-18
00888867473638Arthrex®AR-1288QTT-100AR-1288QTT-1002025-03-18
00888867473645Arthrex®AR-1288QTT-110AR-1288QTT-1102025-03-18
00888867473652Arthrex®AR-1288QTT-80AR-1288QTT-802025-03-18
00888867473669Arthrex®AR-1288QTT-90AR-1288QTT-902025-03-18
00888867034372Arthrex®AR-502-1LAR-502-1L2017-02-15
00888867034389Arthrex®AR-502-1RAR-502-1R2017-02-15
00888867034396Arthrex®AR-502-2LAR-502-2L2017-02-15
00888867034402Arthrex®AR-502-2RAR-502-2R2017-02-15
00888867034570Arthrex®AR-502-3LAR-502-3L2017-02-15
00888867034587Arthrex®AR-502-3RAR-502-3R2017-02-15
00888867034662Arthrex®AR-502-4LAR-502-4L2017-12-06
00888867034679Arthrex®AR-502-4RAR-502-4R2017-02-15
00888867035546Arthrex®AR-504-PSA8AR-504-PSA82017-02-15
00888867035560Arthrex®AR-504-PSC9AR-504-PSC92017-02-15
00888867035577Arthrex®AR-504-PSD0AR-504-PSD02017-02-15
00888867106840Arthrex®AR-504-PSE0AR-504-PSE02017-02-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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