Primary Device ID | 04719886900583 |
NIH Device Record Key | 2560c37d-2908-41bd-bc9c-3d1d4d859bfa |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | U2 Total Knee System |
Version Model Number | 9403-7009-RQ |
Catalog Number | 9403-7009-RQ |
Company DUNS | 656700556 |
Company Name | UNITED ORTHOPEDIC CORP. |
Device Count | 1 |
DM Exempt | false |
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 | |
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 | |
Phone | +886229294567 |
tw.service@unitedorthopedic.com | |
Phone | +886229294567 |
tw.service@unitedorthopedic.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04719886900583 [Primary] |
HWT | Template |
Steralize Prior To Use | true |
Device Is Sterile | false |
[04719886900583]
Moist Heat or Steam Sterilization
[04719886900583]
Moist Heat or Steam Sterilization
[04719886900583]
Moist Heat or Steam Sterilization
[04719886900583]
Moist Heat or Steam Sterilization
[04719886900583]
Moist Heat or Steam Sterilization
[04719886900583]
Moist Heat or Steam Sterilization
[04719886900583]
Moist Heat or Steam Sterilization
[04719886900583]
Moist Heat or Steam Sterilization
[04719886900583]
Moist Heat or Steam Sterilization
[04719886900583]
Moist Heat or Steam Sterilization
[04719886900583]
Moist Heat or Steam Sterilization
[04719886900583]
Moist Heat or Steam Sterilization
[04719886900583]
Moist Heat or Steam Sterilization
[04719886900583]
Moist Heat or Steam Sterilization
[04719886900583]
Moist Heat or Steam Sterilization
[04719886900583]
Moist Heat or Steam Sterilization
[04719886900583]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-12-26 |
Device Publish Date | 2023-12-18 |
04719872178750 | Tibial baseplate driver |
04719872178163 | U2 Knee AiO tibia and inset patella case |
04719872178156 | U2 Knee AiO tibia and onset patella case |
04719872178149 | U2 Knee AiO femur and reusable trial case |
04719872178132 | U2 Knee AiO femur and reusable trial case |
04719872178125 | U2 Knee AiO femur case |
04719872178118 | AiO Case |
04719872178101 | PSA Distal spacer caddy |
04719872178095 | U2 PSA Knee femoral offset case |
04719872178064 | PSA Case #3 |
04719872178026 | U2 Knee size 7 case |
04719872178019 | U2 Knee MIS case |
04719872177999 | U2 Knee CMA case |
04719872177982 | U2 Knee case #4 |
04719872177975 | U2 Knee case #3 |
04719872177968 | Tibial insert trial case |
04719872177951 | U2 Knee case #2 |
04719872177944 | U2 Knee case #1 |
04719872175353 | U2 Knee MIS case |
04719872175339 | U2 Knee case #5 |
04719872174370 | MIS femoral cutting guide, #1 |
04719872174332 | Femoral IM alignment guide , 7°, right |
04719872171348 | Tibial insert trial, CR, plained, #0, 13mm |
04719872171331 | Tibial insert trial, CR, plained, #0, 11mm |
04719872171324 | Tibial insert trial, CR, plained, #0, 11mm |
04719872171317 | Tibial insert trial, CR, plained, #0, 9mm |
04719872170693 | Straight stem trial, PSA, Ø23×150mm |
04719872170686 | Straight stem trial, PSA, ψ21 x 150mm |
04719872170440 | Straight stem trial, PSA, φ23×75mm |
04719872170433 | Straight stem trial, PSA, φ21×75mm |
04719872170198 | Straight stem trial, PSA, φ22×100mm |
04719872170129 | Straight stem trial, PSA, φ24×75mm |
04719872170112 | Straight stem trial, PSA, φ22×75mm |
04719872169000 | Tibial insert trial, CR, plained, #1, 13mm |
04719872168980 | Tibial insert trial, CR, plained, #1, 11mm |
04719872168966 | Tibial insert trial, CR, plained, #1, 9mm |
04719872168942 | Tibial insert trial, CR, plained, #0, 18mm |
04719872168935 | Tibial insert trial, CR, plained, #0, 18mm |
04719872168928 | Tibial insert trial, CR, plained, #0, 15mm |
04719872168911 | Tibial insert trial, CR, plained, #0, 15mm |
04719872168904 | Tibial insert trial, CR, plained, #0, 13mm |
04719872168898 | Tibial insert trial, CR, plained, #0, 9mm |
04719872168751 | Tibial baseplate trial, #0 |
04719872167730 | MIS femoral A/P chamfer cutting guide,#5 |
04719872166399 | Straight stem trial, PSA, φ23×100mm |
04719872166382 | Straight stem trial, PSA, φ21×100mm |
04719872165279 | Tibial insert trial, PS, #7, 18mm |
04719872165255 | Tibial insert trial, PS, #7, 15mm |
04719872165231 | Tibial insert trial, PS, #7, 13mm |
04719872165217 | Tibial insert trial, PS, #7, 11mm |