| Primary Device ID | 04711605587020 |
| NIH Device Record Key | f562cf6b-edde-4544-b74a-00289c0205e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | U2 Femoral Head |
| Version Model Number | 1206-2722-RC |
| Catalog Number | 1206-2722-RC |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04711605587020 [Primary] |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04711605587020]
Moist Heat or Steam Sterilization
[04711605587020]
Moist Heat or Steam Sterilization
[04711605587020]
Moist Heat or Steam Sterilization
[04711605587020]
Moist Heat or Steam Sterilization
[04711605587020]
Moist Heat or Steam Sterilization
[04711605587020]
Moist Heat or Steam Sterilization
[04711605587020]
Moist Heat or Steam Sterilization
[04711605587020]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-24 |
| Device Publish Date | 2022-06-16 |
| 04711605581165 | U2 Femoral head trial, Ø36mm, +10mm |
| 04711605581158 | U2 Femoral head trial, Ø32mm, +10mm |
| 04711605581141 | U2 Femoral head trial, Ø28mm, +10mm |
| 04711605581134 | U2 Femoral head trial, Ø26mm, +9mm |
| 04711605581127 | U2 Femoral head trial, Ø22mm, +9mm |
| 04711605581110 | U2 Femoral head trial, Ø36mm, +7.5mm |
| 04711605581103 | U2 Femoral head trial, Ø32mm, +7.5mm |
| 04711605581097 | U2 Femoral head trial, Ø28mm, +7.5mm |
| 04711605581080 | U2 Femoral head trial, Ø26mm, +6mm |
| 04711605581073 | U2 Femoral head trial, Ø22mm, +6mm |
| 04711605581066 | U2 Femoral head trial, Ø36mm, +5mm |
| 04711605581059 | U2 Femoral head trial, Ø32mm, +5mm |
| 04711605581042 | U2 Femoral head trial, Ø28mm, +5mm |
| 04711605581035 | U2 Femoral head trial, Ø26mm, +3mm |
| 04711605581028 | U2 Femoral head trial, Ø22mm, +3mm |
| 04711605581011 | U2 Femoral head trial, Ø36mm, +2.5mm |
| 04711605581004 | U2 Femoral head trial, Ø32mm, +2.5mm |
| 04711605580991 | U2 Femoral head trial, Ø28mm, +2.5mm |
| 04711605580984 | U2 Femoral head trial, Ø36mm, +0mm |
| 04711605580977 | U2 Femoral head trial, Ø32mm, +0mm |
| 04711605580960 | U2 Femoral head trial, Ø28mm, +0mm |
| 04711605580953 | U2 Femoral head trial, Ø26mm, +0mm |
| 04711605580946 | U2 Femoral head trial, Ø22mm, +0mm |
| 04711605580939 | U2 Femoral head trial, Ø36mm, -3mm |
| 04711605580922 | U2 Femoral head trial, Ø32mm, -3mm |
| 04711605580915 | U2 Femoral head trial, Ø28mm, -3mm |
| 04711605580908 | U2 Femoral head trial, Ø26mm, -2mm |
| 04711605587068 | U2 Femoral head trial, Ø36mm, +10mm |
| 04711605587051 | U2 Femoral head trial, Ø32mm, +10mm |
| 04711605587044 | U2 Femoral head trial, Ø28mm, +10mm |
| 04711605587037 | U2 Femoral head trial, Ø26mm, +9mm |
| 04711605587020 | U2 Femoral head trial, Ø22mm, +9mm |
| 04711605587013 | U2 Femoral head trial, Ø36mm, +7.5mm |
| 04711605587006 | U2 Femoral head trial, Ø32mm, +7.5mm |
| 04711605586993 | U2 Femoral head trial, Ø28mm, +7.5mm |
| 04711605586986 | U2 Femoral head trial, Ø26mm, +6mm |
| 04711605586979 | U2 Femoral head trial, Ø22mm, +6mm |
| 04711605586962 | U2 Femoral head trial, Ø36mm, +5mm |
| 04711605586955 | U2 Femoral head trial, Ø32mm, +5mm |
| 04711605586948 | U2 Femoral head trial, Ø28mm, +5mm |
| 04711605586931 | U2 Femoral head trial, Ø26mm, +3mm |
| 04711605586924 | U2 Femoral head trial, Ø22mm, +3mm |
| 04711605586917 | U2 Femoral head trial, Ø36mm, +2.5mm |
| 04711605586900 | U2 Femoral head trial, Ø32mm, +2.5mm |
| 04711605586894 | U2 Femoral head trial, Ø28mm, +2.5mm |
| 04711605586887 | U2 Femoral head trial, Ø36mm, +0mm |
| 04711605586870 | U2 Femoral head trial, Ø32mm, +0mm |
| 04711605586863 | U2 Femoral head trial, Ø28mm, +0mm |
| 04711605586856 | U2 Femoral head trial, Ø26mm, +0mm |
| 04711605586849 | U2 Femoral head trial, Ø22mm, +0mm |