DURALOC 124546503

GUDID 10603295019442

DURALOC ACETABULAR CUP SYSTEM BANTAM ACETABULAR SHELL 46mm OD

DEPUY ORTHOPAEDICS, INC.

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell

• Primary Device ID: 10603295019442
• NIH Device Record Key: 97e8ce64-818d-42b1-bbe0-7fa7587f4f86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURALOC
• Version Model Number: 1245-46-503
• Catalog Number: 124546503
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295019442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K900832

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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: 2020-09-09
• 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