| Primary Device ID | 04719872168003 |
| NIH Device Record Key | 1dd4b189-2433-4ca0-a685-61b344aeb808 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | U2 Acetabular Components |
| Version Model Number | 1303-2054-RA |
| Catalog Number | 1303-2054-RA |
| 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 | true |
| 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 | 04719872168003 [Primary] |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04719872168003]
Moist Heat or Steam Sterilization
[04719872168003]
Moist Heat or Steam Sterilization
[04719872168003]
Moist Heat or Steam Sterilization
[04719872168003]
Moist Heat or Steam Sterilization
[04719872168003]
Moist Heat or Steam Sterilization
[04719872168003]
Moist Heat or Steam Sterilization
[04719872168003]
Moist Heat or Steam Sterilization
[04719872168003]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-12 |
| Device Publish Date | 2022-07-04 |
| 04719872177869 | U2 Acetabular case |
| 04719872177852 | Acetabular MIS case |
| 04719872173571 | U2 Acetabular case |
| 04719872173564 | Screw set case |
| 04719872173557 | Acetabular MIS case |
| 04719872173540 | MIS set case |
| 04719872173533 | Cup reamer set case |
| 04719872140153 | Flexible drill, 75mm |
| 04719872140146 | Acetabular MIS case |
| 04719872161271 | XPE cup liner trial, ID 32mm, 10°x58mm |
| 04719872161158 | XPE cup liner trial, ID 28mm, 10°x58mm |
| 04719872161561 | Acetabular cup liner trial, ID 26mm, 10°×46mm |
| 04719872161554 | Acetabular cup liner trial, ID26mm, 10°×44mm |
| 04719872168447 | U2 Acetabular cup liner trial, ID26mm, 10°×62mm |
| 04719872168430 | U2 Acetabular cup liner trial, ID26mm, 10°×60mm |
| 04719872168423 | U2 Acetabular cup liner trial, ID26mm, 10°×58mm |
| 04719872168416 | U2 Acetabular cup liner trial, ID26mm, 10°×56mm |
| 04719872168409 | U2 Acetabular cup liner trial, ID26mm, 10°×54mm |
| 04719872168393 | U2 Acetabular cup liner trial, ID26mm, 10°×52mm |
| 04719872168386 | U2 Acetabular cup liner trial, ID26mm, 10°×50mm |
| 04719872168379 | U2 Acetabular cup liner trial, ID26mm, 10°×48mm |
| 04719872168164 | Cup trial, φ70mm |
| 04719872168140 | Cup trial, φ68mm |
| 04719872168126 | Cup trial, φ66mm |
| 04719872168102 | Cup trial, φ64mm |
| 04719872168089 | Cup trial, φ62mm |
| 04719872168065 | Cup trial, φ60mm |
| 04719872168041 | Cup trial, φ58mm |
| 04719872168027 | Cup trial, φ56mm |
| 04719872168003 | Cup trial, φ54mm |
| 04719872167983 | Cup trial, φ52mm |
| 04719872167969 | Cup trial, φ50mm |
| 04719872167945 | Cup trial, φ48mm |
| 04719872167921 | Cup trial, φ46mm |
| 04719872167907 | Cup trial, φ44mm |
| 04719872167884 | Cup trial, φ42mm |