| Primary Device ID | 10603295179061 |
| NIH Device Record Key | f2f9f5ed-dba5-4922-822b-3f0984938c3c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | S-ROM NOILES |
| Version Model Number | 62-1630 |
| Catalog Number | 621630 |
| 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 |
| 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 | 10603295179061 [Primary] |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-02-05 |
| Device Publish Date | 2015-09-24 |
| 10603295181880 | S-ROM NOILES PATELLAR CEMENT CLAMP |
| 10603295180722 | S-ROM NOILES AUGMENT BLOCK CEMENT CLAMP |
| 10603295179856 | S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 21mm x 100mm |
| 10603295179849 | S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 19mm x 100mm |
| 10603295179832 | S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 17mm x 100mm |
| 10603295179825 | S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 15mm x 150mm |
| 10603295179818 | S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 15mm x 100mm |
| 10603295179801 | S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 13mm x 150mm |
| 10603295179795 | S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 13mm x 100mm |
| 10603295179788 | S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 11mm x 150mm |
| 10603295179771 | S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 11mm x 100mm |
| 10603295179764 | S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 9mm x 150mm |
| 10603295179757 | S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 9mm x 100mm |
| 10603295181798 | S-ROM NOILES PATELLAR REAMER 32mm |
| 10603295181781 | S-ROM NOILES PATELLAR REAMER 35mm |
| 10603295181774 | S-ROM NOILES PATELLAR REAMER 38mm |
| 10603295181767 | S-ROM NOILES PATELLAR REAMER 30mm |
| 10603295178286 | S-ROM NOILES PATELLAR INSTRUMENTS - CASE Number 7 |
| 10603295093756 | S-ROM NOILES HINGE FEMORAL PREP TRAY |
| 10603295093732 | S-ROM NOILES HINGE FEMORAL PREP BASE |
| 10603295093725 | S-ROM NOILES HINGE FEMORAL PREP LID |
| 10603295093718 | S-ROM NOILES HINGE FEMORAL PREP SET |
| 10603295179092 | S-ROM NOILES PATELLA DOME 38mm X 10mm |
| 10603295179085 | S-ROM NOILES PATELLA DOME 35mm X 9mm |
| 10603295179078 | S-ROM NOILES PATELLA DOME 32mm X 8.5mm |
| 10603295179061 | S-ROM NOILES PATELLA DOME 30mm X 8mm |
| 10603295181606 | S-ROM NOILES ROTATING HINGE FEMORAL TRIAL X-SMALL RIGHT |
| 10603295181590 | S-ROM NOILES ROTATING HINGE FEMORAL TRIAL X-SMALL LEFT |
| 10603295181583 | S-ROM NOILES ROTATING HINGE BOX TRIAL |
| 10603295181576 | S-ROM NOILES ROTATING HINGE FEMORAL TRIAL SMALL RIGHT |
| 10603295181569 | S-ROM NOILES ROTATING HINGE FEMORAL TRIAL SMALL LEFT |
| 10603295181521 | S-ROM NOILES HINGE PIN TRIAL |
| 10603295181514 | S-ROM NOILES ROTATING HINGE FEMORAL TRIAL MEDIUM LEFT |
| 10603295181507 | S-ROM NOILES ROTATING HINGE FEMORAL TRIAL MEDIUM RIGHT |
| 10603295180845 | S-ROM NOILES POSTERIOR STABILIZED FEM AUGMENT TRIAL-COMBO 10/10mm MED/LG/XLG |
| 10603295180838 | S-ROM NOILES PS FEMORAL AUGMENT TRIAL - COMBO 10/5mm MED/LG/XLG |
| 10603295180821 | S-ROM NOILES POSTERIOR STABILIZED FEM AUGMENT TRIAL-COMBO 5/5mm MED/LG/XLG |
| 10603295180814 | S-ROM NOILES POSTERIOR STABILIZED FEM AUGMENT TRIAL-POSTERIOR 10mm MED/LG/XLG |
| 10603295180791 | S-ROM NOILES POSTERIOR STABILIZED FEM AUGMENT TRIAL-DISTAL 10mm MED/LG/XLG |
| 10603295180784 | S-ROM NOILES POSTERIOR STABILIZED FEM AUGMENT TRIAL-DISTAL 5mm MED/LG/XLG |
| 10603295180654 | S-ROM NOILES ROTATING HINGE FEMORAL AUGMENT TRIAL - DISTAL 10mm |
| 10603295180647 | S-ROM NOILES ROTATING HINGE FEMORAL AUGMENT TRIAL - DISTAL 5mm |
| 10603295181873 | S-ROM NOILES PATELLAR RESTRAINING INSTRUMENT |
| 10603295180043 | S-ROM NOILES BONE DRILL - LONG 3.2mm |
| 10603295181835 | S-ROM NOILES PATELLAR REAMER DEPTH ADJUSTER 38mm |
| 10603295181828 | S-ROM NOILES PATELLAR REAMER DEPTH ADJUSTER 35mm |
| 10603295181811 | S-ROM NOILES PATELLAR REAMER DEPTH ADJUSTER 32mm |
| 10603295181804 | S-ROM NOILES PATELLAR REAMER DEPTH ADJUSTER 30mm |
| 10603295180692 | S-ROM NOILES IMPACTION CAP |
| 10603295180661 | S-ROM NOILES TIBIAL TRAY DRIVER |