| Primary Device ID | 04719872142577 |
| NIH Device Record Key | 54250478-ac4d-4f6b-ad0f-7a77cc5b2e3a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | U-Motion II |
| Version Model Number | 9206-1103-RH |
| Catalog Number | 9206-1103-RH |
| Company DUNS | 656700556 |
| Company Name | UNITED ORTHOPEDIC CORP. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719872142577 [Primary] |
| HWA | Impactor |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04719872142577]
Moist Heat or Steam Sterilization
[04719872142577]
Moist Heat or Steam Sterilization
[04719872142577]
Moist Heat or Steam Sterilization
[04719872142577]
Moist Heat or Steam Sterilization
[04719872142577]
Moist Heat or Steam Sterilization
[04719872142577]
Moist Heat or Steam Sterilization
[04719872142577]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-07 |
| Device Publish Date | 2022-06-29 |
| 04719872162162 | U-Motion II Acetabular liner trial, 20°, ID28mm, OD46mm |
| 04719872162049 | U-Motion II Acetabular liner trial, 20°, ID36mm, OD50mm |
| 04719872161912 | U-Motion II Acetabular liner trial, 20°, ID32mm, OD46mm |
| 04719872161707 | U-Motion II Acetabular liner trial, 0°, ID36mm, OD50mm |
| 04719872161677 | U-Motion II Acetabular liner trial, 0°, ID32mm, OD46mm |
| 04719872160922 | Acetabular cup trial, 42mm |
| 04711605582667 | Cup orientation handle, curved |
| 04711605582643 | Cup orientation handle, straight |
| 04711605582476 | Cup orientor, small |
| 04711605581950 | Cup impactor, 230mm |
| 04711605581943 | Final cup impactor, large |
| 04711605589857 | Cup impactor, offset |
| 04719872141525 | Cup impactor driver |
| 04719872141518 | U-Motion II Acetabular liner trial, ID32mm, OD70mm |
| 04719872141501 | U-Motion II Acetabular liner trial, ID32mm, OD68mm |
| 04719872141495 | U-Motion II Acetabular liner trial, ID32mm, OD66mm |
| 04719872141488 | U-Motion II Acetabular liner trial, ID32mm, OD64mm |
| 04719872141471 | U-Motion II Acetabular liner trial, ID32mm, OD62mm |
| 04719872141464 | U-Motion II Acetabular liner trial, ID32mm, OD60mm |
| 04719872141457 | U-Motion II Acetabular liner trial, ID32mm, OD58mm |
| 04719872141440 | U-Motion II Acetabular liner trial, ID32mm, OD56mm |
| 04719872141433 | U-Motion II Acetabular liner trial, ID32mm, OD54mm |
| 04719872141426 | U-Motion II Acetabular liner trial, ID32mm, OD52mm |
| 04711605586658 | Ceramic femoral head trial, Delta, Ø28mm, S, -2.5mm |
| 04711605586795 | Ceramic femoral head trial, Delta, Ø40mm, XL, +9mm |
| 04711605586788 | Ceramic femoral head trial, Delta, Ø36mm, XL, +9mm |
| 04711605586771 | Ceramic femoral head trial, Delta, Ø32mm, XL, +8mm |
| 04711605586764 | Ceramic femoral head trial, Delta, Ø40mm, L, +5mm |
| 04711605586757 | Ceramic femoral head trial, Delta, Ø36mm, L, +5mm |
| 04711605586740 | Ceramic femoral head trial, Delta, Ø32mm, L, +5mm |
| 04711605586733 | Ceramic femoral head trial, Delta, Ø28mm, L, +4mm |
| 04711605586726 | Ceramic femoral head trial, Delta, Ø40mm, M, +1mm |
| 04711605586719 | Ceramic femoral head trial, Delta, Ø36mm, M, +1mm |
| 04711605586702 | Ceramic femoral head trial, Delta, Ø32mm, M, +1mm |
| 04711605586696 | Ceramic femoral head trial, Delta, Ø28mm, M, +1mm |
| 04711605586689 | Ceramic femoral head trial, Delta, Ø40mm, S, -3mm |
| 04711605586672 | Ceramic femoral head trial, Delta, Ø36mm, S, -3mm |
| 04711605586665 | Ceramic femoral head trial, Delta, Ø32mm, S, -3mm |
| 04719886891034 | Universal screw driver |
| 04719886891027 | Straight screw driver |
| 04719872142577 | Cup impactor |
| 04719872142164 | Liner impactor, 22mm |
| 04719886893472 | Alignment tower |
| 04719872179276 | Cup impactor |
| 04719872143178 | Cup impactor, 380mm |
| 04719872143161 | Final cup impactor, large |
| 04719872143154 | Cup impactor, 300mm |
| 04719872143109 | Trial locking screw |
| 04719886893755 | Liner impactor, 36mm |
| 04719886893748 | Liner impactor, 32mm |