| Primary Device ID | 04719872179368 |
| NIH Device Record Key | e7f00afc-53fe-495d-9cea-408ffd0d7b65 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | U1™ Hip |
| Version Model Number | 9601-1213-RD |
| Catalog Number | 9601-1213-RD |
| 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 |
| service@uoc.com.tw |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719872179368 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04719872179368]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2018-10-05 |
| Device Publish Date | 2017-07-14 |
| 04719872179368 | Universal screw driver |
| 04719872179351 | Universal screw driver |
| 04719872179344 | Screw driver, straight |
| 04719872179337 | Screw forceps, 45°, auto-fix |
| 04719872179184 | Cap liner & head trial remover |
| 04719872179177 | Drill guide |
| 04719872179160 | Universal cup locator block,assm. |
| 04719872179153 | Cup locator rod |
| 04719872179146 | Acetabular cup locator assembly |
| 04719872179078 | Vertical alignment rod |
| 04719872179061 | Femoral head impactor, long |
| 04719872179054 | Sliding hammer |
| 04719872179047 | Reamer T-handle |
| 04719872177616 | Screw driver, flexible |
| 04719872173625 | U2 Cup liner impactor, I.D. 28mm |
| 04719872173618 | U2 Cup liner impactor, I.D. 26mm |
| 04719872173489 | Flexible drill , 50mm |
| 04719872173465 | Flexible drill , 35mm |
| 04719872173441 | Flexible drill, 25mm |
| 04719872173427 | Flexible drill, 15mm |
| 04719872173045 | Cup reamer handle |
| 04719872173038 | Cup reamer handle |
| 04719872173021 | Cup reamer handle |
| 04719872173007 | Depth gauge |
| 04719872172994 | Cup liner extractor |
| 04719872172987 | Cap liner & head trial remover |
| 04719872172970 | Straight drill |
| 04719872172963 | Drill guide |
| 04719872171591 | T-handle stem reamer |
| 04719872171584 | Cap liner guide |
| 04719872171577 | Femoral head extractor |
| 04719872171560 | Femoral cutting chisel |
| 04719872167914 | Cup trial, φ46mm |
| 04719872167891 | Cup trial, φ44mm |
| 04719872162247 | Cap trial, 54mm |