| Primary Device ID | 04719872173410 |
| NIH Device Record Key | bbba9f6a-e8c9-4a62-bcb2-8be51edb103b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | U2™ Hip |
| Version Model Number | 9203-4070 |
| Catalog Number | 9203-4070 |
| 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 Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719872173410 [Primary] |
| HTO | Reamer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04719872173410]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-05-31 |
| Device Publish Date | 2017-06-27 |
| 04719872179245 | U2 Cup liner impactor, I.D. 28mm |
| 04719872179238 | U2 Cup liner impactor, I.D. 26mm |
| 04719872179122 | Broach handle |
| 04719872179115 | Neck trial, #0 |
| 04719872179108 | Stem impactor, long |
| 04719872177876 | U2 XPE case |
| 04719872173830 | Cup impactor, offset |
| 04719872173816 | Cup reamer handle, offset |
| 04719872173755 | Size plate, XPE hip |
| 04719872173496 | Flexible drill, 50mm |
| 04719872173472 | Flexible drill, 35mm |
| 04719872173458 | Flexible drill, 25mm |
| 04719872173434 | Flexible drill, 15mm |
| 04719872173410 | Cup reamer, 70mm |
| 04719872173403 | Cup reamer, 69mm |
| 04719872173397 | Cup reamer, 68mm |
| 04719872173380 | Cup reamer, 67mm |
| 04719872173373 | Cup reamer, 66mm |
| 04719872173366 | Cup reamer, 65mm |
| 04719872173359 | Cup reamer, 64mm |
| 04719872173342 | Cup reamer, 63mm |
| 04719872173335 | Cup reamer, 62mm |
| 04719872173328 | Cup reamer, 61mm |
| 04719872173311 | Cup reamer, 60mm |
| 04719872173304 | Cup reamer, 59mm |
| 04719872173298 | Cup reamer, 58mm |
| 04719872173281 | Cup reamer, 57mm |
| 04719872173274 | Cup reamer, 56mm |
| 04719872173267 | Cup reamer, 55mm |
| 04719872173250 | Cup reamer, 54mm |
| 04719872173243 | Cup reamer, 53mm |
| 04719872173236 | Cup reamer, 52mm |
| 04719872173229 | Cup reamer, 51mm |
| 04719872173212 | Cup reamer, 50mm |
| 04719872173205 | Cup reamer, 49mm |
| 04719872173199 | Cup reamer, 48mm |
| 04719872173182 | Cup reamer, 47mm |
| 04719872173175 | Cup reamer, 46mm |
| 04719872173168 | Cup reamer, 45mm |
| 04719872173151 | Cup reamer, 44mm |
| 04719872173144 | Cup reamer, 43mm |
| 04719872173137 | Cup reamer, 42mm |
| 04719872173120 | Cup reamer, 41mm |
| 04719872173113 | Cup reamer, 40mm |
| 04719872173106 | Cup reamer, 39mm |
| 04719872173090 | Cup reamer, 38mm |
| 04719872173083 | Cup reamer, 37mm |
| 04719872173076 | Cup reamer, 36mm |
| 04719872173069 | Cup locator block |
| 04719872173052 | Full XPE cup positioner |