DURALOC 124146526

GUDID 10603295019008

DURALOC ACETABULAR CUP SYSTEM ENDURON BANTAM ACETABULAR LINER 10 DEGREE 22.225mm ID 46mm OD

DEPUY ORTHOPAEDICS, INC.

Non-constrained polyethylene acetabular liner

• Primary Device ID: 10603295019008
• NIH Device Record Key: f5c1d444-ae63-4d0d-8d5b-16ab51a1944d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURALOC
• Version Model Number: 1241-46-526
• Catalog Number: 124146526
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295019008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944538

FDA Product Code

• JDB: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-09-25
• Device Publish Date: 2015-09-24

On-Brand Devices [DURALOC]

• 10603295107491: DURALOC POLY EXTRACTOR
• 10603295082392: DURALOC CONST LNR RING STARTER 32mm
• 10603295082385: DURALOC CONST LNR RING STARTER 28mm
• 10603295506058: DURALOC MAKE TO ORDER CUP IMPACTOR WITH EXCEL HANDLE 16IN
• 10603295502333: DURALOC MAKE TO ORDER Cup Impactor Shaft 21 IN
• 10603295502326: DURALOC MAKE TO ORDER Cup Impactor Shaft 18 IN
• 10603295502258: DURALOC MAKE TO ORDER Cup Impactor Shaft 15 IN
• 10603295019831: DURALOC DYNAMIC LOCKING RING 66mm
• 10603295019824: DURALOC DYNAMIC LOCKING RING 64mm
• 10603295019817: DURALOC DYNAMIC LOCKING RING 62/74mm
• 10603295019800: DURALOC DYNAMIC LOCKING RING 60/72mm
• 10603295019794: DURALOC DYNAMIC LOCKING RING 58/70mm
• 10603295019787: DURALOC DYNAMIC LOCKING RING 54/68mm
• 10603295019770: DURALOC DYNAMIC LOCKING RING 54mm
• 10603295019763: DURALOC DYNAMIC LOCKING RING 52mm
• 10603295019756: DURALOC DYNAMIC LOCKING RING 50mm
• 10603295019749: DURALOC DYNAMIC LOCKING RING 48mm
• 10603295019732: DURALOC BANTAM DYNAMIC LOCKING RING 46mm
• 10603295019725: DURALOC BANTAM DYNAMIC LOCKING RING 44mm
• 10603295019718: DURALOC BANTAM DYNAMIC LOCKING RING 42mm
• 10603295019701: DURALOC BANTAM DYNAMIC LOCKING RING 40mm
• 10603295019695: DURALOC BANTAM DYNAMIC LOCKING RING 38mm
• 10603295019442: DURALOC ACETABULAR CUP SYSTEM BANTAM ACETABULAR SHELL 46mm OD
• 10603295019435: DURALOC ACETABULAR CUP SYSTEM BANTAM ACETABULAR SHELL 44mm OD
• 10603295019428: DURALOC ACETABULAR CUP SYSTEM BANTAM ACETABULAR SHELL 42mm OD
• 10603295019411: DURALOC ACETABULAR CUP SYSTEM BANTAM ACETABULAR SHELL 40mm OD
• 10603295019404: DURALOC ACETABULAR CUP SYSTEM BANTAM ACETABULAR SHELL 38mm OD
• 10603295148999: DURALOC CASE
• 10603295107545: DURALOC POLY TRIAL TRAY 64mm-74mm
• 10603295107538: DURALOC POLY TRIAL TRAY 48mm-62mm
• 10603295107514: DURALOC POLY EXTR/IMPACTOR TRAY
• 10603295107507: DURALOC IMPACTION INSTRUMENT TRAY
• 10603295108610: DURALOC THREAD SCREW - IN TRIAL SIZER 74mm
• 10603295108603: DURALOC THREAD SCREW - IN TRIAL SIZER 72mm
• 10603295108597: DURALOC THREAD SCREW - IN TRIAL SIZER 70mm
• 10603295108573: DURALOC THREAD SCREW - IN TRIAL SIZER 68mm
• 10603295108559: DURALOC THREAD SCREW - IN TRIAL SIZER 66mm
• 10603295108535: DURALOC THREAD SCREW - IN TRIAL SIZER 64mm
• 10603295108511: DURALOC THREAD SCREW - IN TRIAL SIZER 62mm
• 10603295108498: DURALOC THREAD SCREW - IN TRIAL SIZER 60mm
• 10603295108474: DURALOC THREAD SCREW - IN TRIAL SIZER 58mm
• 10603295108450: DURALOC THREAD SCREW - IN TRIAL SIZER 56mm
• 10603295108436: DURALOC THREAD SCREW - IN TRIAL SIZER 54mm
• 10603295108412: DURALOC THREAD SCREW - IN TRIAL SIZER 52mm
• 10603295108399: DURALOC THREAD SCREW - IN TRIAL SIZER 50mm
• 10603295108375: DURALOC THREAD SCREW - IN TRIAL SIZER 48mm
• 10603295108344: DURALOC THREAD SCREW - IN TRIAL SIZER 46mm
• 10603295108146: DURALOC TRIAL LINER 28mm ID 50mm OD +4
• 10603295108139: DURALOC TRIAL LINER 28mm ID 48mm OD +4
• 10603295108122: DURALOC TRIAL LINER 32mm ID 66mm OD +4