| Primary Device ID | 03701037300510 |
| NIH Device Record Key | 0d847b9a-1d2f-44b0-828d-d0b7381d998e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Humelock Cemented Shoulder System |
| Version Model Number | 106-5000 |
| Company DUNS | 263076196 |
| Company Name | FX SOLUTIONS |
| 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 | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701037300510 [Primary] |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-30 |
| Device Publish Date | 2024-01-22 |
| 03701037302149 - PRCT II | 2024-08-14 LOCKING SCREW TA6V Ø4.5mm L.55mm |
| 03701037302194 - PRCT II | 2024-08-14 STANDARD SCREW TA6V Ø4.5mm L.16mm |
| 03701037302200 - PRCT II | 2024-08-14 STANDARD SCREW TA6V Ø4.5mm L.18mm |
| 03701037302286 - PRCT II | 2024-08-14 STANDARD SCREW TA6V Ø4.5mm L.55mm |
| 03701037302576 - PRCT II | 2024-08-14 STANDARD SCREW TA6V Ø4.5mm L.34mm |
| 03701037302590 - PRCT II | 2024-08-14 STANDARD SCREW TA6V Ø4.5mm L.38mm |
| 03701037302606 - PRCT II | 2024-08-14 STANDARD SCREW TA6V Ø4.5mm L.42mm |
| 03701037320525 - FX V135® Shoulder Prothesis | 2024-08-13 RESURFACING GLENOID REAMER Ø54mm |