| Primary Device ID | 10603295551904 |
| NIH Device Record Key | 1888b1b1-69d0-4c59-97f1-01cc748f4d76 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INHANCE SHOULDER SYSTEM |
| Version Model Number | 7702-20-400 |
| Catalog Number | 770220400 |
| Company DUNS | 989365556 |
| Company Name | DEPUY (IRELAND) |
| 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 | true |
| 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 | 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 | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10603295551904 [Primary] |
| HTO | REAMER |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-03 |
| Device Publish Date | 2025-02-21 |
| 10603295560050 | INHANCE SHOULDER SYSTEM DRIVER NA NA |
| 10603295551935 | INHANCE SHOULDER SYSTEM HUMERAL PREP KIT EXTRA SMALL NA |
| 10603295551928 | INHANCE SHOULDER SYSTEM HUMERAL PREP KIT EXTRA LARGE NA |
| 10603295551911 | INHANCE SHOULDER SYSTEM HUMERAL PREP KIT SMALL NA |
| 10603295551904 | INHANCE SHOULDER SYSTEM HUMERAL PREP KIT MEDIUM NA |
| 10603295551898 | INHANCE SHOULDER SYSTEM HUMERAL PREP KIT LARGE NA |
| 10603295551874 | INHANCE SHOULDER SYSTEM GLENOID PREP KIT EXTRA LARGE NA |
| 10603295551843 | INHANCE SHOULDER SYSTEM GLENOID PREP KIT LARGE NA |
| 10603295551805 | INHANCE SHOULDER SYSTEM READY- SET GO REVERSE KIT NA NA |
| 10603295551799 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL KIT 44 - 51mm NA |
| 10603295551782 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL KIT 38 - 44mm NA |
| 10603295551775 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL KIT 51 - 57mm NA |
| 10603295551881 | INHANCE SHOULDER SYSTEM GLENOID PREP KIT EXTRA SMALL NA |
| 10603295551867 | INHANCE SHOULDER SYSTEM GLENOID PREP KIT SMALL NA |
| 10603295551850 | INHANCE SHOULDER SYSTEM GLENOID PREP KIT MEDIUM NA |
| 10603295551836 | INHANCE SHOULDER SYSTEM GLENOSPHERE EXTRACTOR TIP NA NA |
| 10603295551829 | INHANCE SHOULDER SYSTEM TAPER AND SHELL EXTRACTOR TIP NA NA |
| 10603295551768 | INHANCE SHOULDER SYSTEM READY-SET GO GENERAL KIT NA NA |