| Primary Device ID | 10603295108344 |
| NIH Device Record Key | 6b97082b-5be6-4392-920b-279474d2c002 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DURALOC |
| Version Model Number | 2252-46-000 |
| Catalog Number | 225246000 |
| Company DUNS | 080506581 |
| Company Name | DEPUY ORTHOPAEDICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10603295108344 [Primary] |
| HWT | TEMPLATE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10603295108344]
Moist Heat or Steam Sterilization
[10603295108344]
Moist Heat or Steam Sterilization
[10603295108344]
Moist Heat or Steam Sterilization
[10603295108344]
Moist Heat or Steam Sterilization
[10603295108344]
Moist Heat or Steam Sterilization
[10603295108344]
Moist Heat or Steam Sterilization
[10603295108344]
Moist Heat or Steam Sterilization
[10603295108344]
Moist Heat or Steam Sterilization
[10603295108344]
Moist Heat or Steam Sterilization
[10603295108344]
Moist Heat or Steam Sterilization
[10603295108344]
Moist Heat or Steam Sterilization
[10603295108344]
Moist Heat or Steam Sterilization
[10603295108344]
Moist Heat or Steam Sterilization
[10603295108344]
Moist Heat or Steam Sterilization
[10603295108344]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-12-21 |
| Device Publish Date | 2018-09-24 |
| 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 |