| Primary Device ID | 04719872155492 |
| NIH Device Record Key | a04a37f2-9b63-46b5-a5d7-eaec00260eac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | U2 Femoral head, 4/5 polished, Ø28mm, +7.5mm |
| Version Model Number | 1206-5628 |
| Catalog Number | 1206-5628 |
| Company DUNS | 656700556 |
| Company Name | UNITED ORTHOPEDIC CORP. |
| 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 | +886229294567 |
| service@uoc.com.tw |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719872155492 [Primary] |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-08-08 |
| Device Publish Date | 2017-10-06 |
| 04719886910919 - UCP Stem | 2025-11-24 UCP Neck trial, standard |
| 04719886910926 - UCP Stem | 2025-11-24 UCP Neck trial, high offset |
| 04719886911183 - Resolve Modular Revision Stem | 2025-11-24 Transition reamer |
| 04719886910650 - UTF Hip Stem | 2025-11-21 UTF-r Femoral broach tray |
| 04719886910667 - UTF Hip Stem | 2025-11-21 UTF-r Femoral prep tray |
| 04719886910674 - UTF Hip Stem | 2025-11-21 UTF-r Straight/offset tray |
| 04719886910681 - UTF Hip Stem | 2025-11-21 UTF-r Dual offset tray |
| 04719886910698 - UTF Hip Stem | 2025-11-21 United femoral head trial tray |