| Primary Device ID | 04711605587679 |
| NIH Device Record Key | a5d042bb-e6d0-4ee7-9990-a8c6608c34ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | USTAR II Knee System |
| Version Model Number | 2115-2210 |
| 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 |
| service@uoc.com.tw | |
| Phone | +886229294567 |
| service@uoc.com.tw | |
| Phone | +886229294567 |
| service@uoc.com.tw | |
| Phone | +886229294567 |
| service@uoc.com.tw | |
| Phone | +886229294567 |
| service@uoc.com.tw | |
| Phone | +886229294567 |
| service@uoc.com.tw | |
| Phone | +886229294567 |
| service@uoc.com.tw | |
| Phone | +886229294567 |
| service@uoc.com.tw | |
| Phone | +886229294567 |
| service@uoc.com.tw | |
| Phone | +886229294567 |
| service@uoc.com.tw | |
| Phone | +886229294567 |
| service@uoc.com.tw | |
| Phone | +886229294567 |
| service@uoc.com.tw | |
| Phone | +886229294567 |
| service@uoc.com.tw |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04711605587679 [Primary] |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04711605587679]
Moist Heat or Steam Sterilization
[04711605587679]
Moist Heat or Steam Sterilization
[04711605587679]
Moist Heat or Steam Sterilization
[04711605587679]
Moist Heat or Steam Sterilization
[04711605587679]
Moist Heat or Steam Sterilization
[04711605587679]
Moist Heat or Steam Sterilization
[04711605587679]
Moist Heat or Steam Sterilization
[04711605587679]
Moist Heat or Steam Sterilization
[04711605587679]
Moist Heat or Steam Sterilization
[04711605587679]
Moist Heat or Steam Sterilization
[04711605587679]
Moist Heat or Steam Sterilization
[04711605587679]
Moist Heat or Steam Sterilization
[04711605587679]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-21 |
| Device Publish Date | 2020-02-13 |
| 04711605584999 | Torque wrench |
| 04711605584982 | Screw driver adaptor, T30 |
| 04711605584975 | Torque wrench adaptor, Ø9mm |
| 04711605588010 | USTAR II Press-fit stem trial adaptor, Ø17mm |
| 04711605588003 | USTAR II Press-fit stem trial adaptor, Ø15mm |
| 04711605587990 | USTAR II Press-fit stem trial adaptor, Ø13mm |
| 04711605587983 | USTAR II Press-fit stem trial adaptor, Ø11mm |
| 04711605587624 | USTAR II Femoral trial, hinged, #2, left |
| 04711605587617 | USTAR II Femoral trial, hinged, #1, left |
| 04711605586191 | USTAR II Femoral trial, hinged, #0, left |
| 04711605588218 | Tibial stem trial, Ø14×120mm |
| 04711605588201 | Tibial stem trial, Ø12.5×120mm |
| 04711605588195 | Tibial stem trial, Ø14×95mm |
| 04711605588188 | Tibial stem trial, Ø12.5×95mm |
| 04711605588171 | Tibial stem trial, Ø14×70mm |
| 04711605588164 | Tibial stem trial, Ø12.5×70mm |
| 04711605588157 | Tibial stem trial, Ø14×45mm |
| 04711605588140 | Tibial stem trial, Ø12.5×45mm |
| 04711605588034 | USTAR II Distal femoral trial, RHS, XS, right |
| 04711605588027 | USTAR II Distal femoral trial, RHS, XS, left |
| 04711605587723 | USTAR II Femoral trial, hinged, #6, right |
| 04711605587716 | USTAR II Femoral trial, hinged, #5, right |
| 04711605587709 | USTAR II Femoral trial, hinged, #4, right |
| 04711605587693 | USTAR II Femoral trial, hinged, #3, right |
| 04711605587686 | USTAR II Femoral trial, hinged, #2, right |
| 04711605587679 | USTAR II Femoral trial, hinged, #1, right |
| 04711605587662 | USTAR II Femoral trial, hinged, #6, left |
| 04711605587655 | USTAR II Femoral trial, hinged, #5, left |
| 04711605587648 | USTAR II Femoral trial, hinged, #4, left |
| 04711605587631 | USTAR II Femoral trial, hinged, #3, left |
| 04711605586207 | USTAR II Femoral trial, hinged, #0, right |
| 04711605584951 | Cemented tibial stem trial, Ø9×120mm |
| 04711605588300 | USTAR II Segment part trial, RHS, bridge, 80mm |
| 04711605587853 | USTAR II Press-fit stem trial body, straight, Ø11×150mm |
| 04711605587846 | USTAR II Press-fit stem trial body, curved, Ø17×200mm |
| 04711605587839 | USTAR II Press-fit stem trial body, curved, Ø15×200mm |
| 04711605587822 | USTAR II Press-fit stem trial body, curved, Ø13×200mm |
| 04711605587815 | USTAR II Press-fit stem trial body, curved, Ø11×200mm |
| 04711605587808 | USTAR II Press-fit stem trial body, curved, Ø17×150mm |
| 04711605587792 | USTAR II Press-fit stem trial body, curved, Ø15×150mm |
| 04711605587785 | USTAR II Press-fit stem trial body, curved, Ø13×150mm |
| 04711605587778 | USTAR II Press-fit stem trial body, curved, Ø11×150mm |
| 04711605584968 | Cemented tibial stem trial, Ø9×145mm |
| 04719872140160 | USTAR II Stem trial driver |
| 04711605589109 | USTAR II Femoral A/P chamfer cutting guide, #5 |
| 04711605589093 | USTAR II Femoral A/P chamfer cutting guide, #4 |
| 04711605589086 | USTAR II Femoral A/P chamfer cutting guide, #3 |
| 04711605589079 | USTAR II Femoral A/P chamfer cutting guide, #2 |
| 04711605589062 | USTAR II Femoral A/P chamfer cutting guide, #1 |
| 04711605589055 | Box cutting guide |