| Primary Device ID | 04711605585347 |
| NIH Device Record Key | 4e4e0384-c01f-42f0-87ed-72fe59da7c26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UTS Hip Stem |
| Version Model Number | 9116-3001-RB |
| Catalog Number | 9116-3001-RB |
| 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 | |
| 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 | 04711605585347 [Primary] |
| HWB | Extractor |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04711605585347]
Moist Heat or Steam Sterilization
[04711605585347]
Moist Heat or Steam Sterilization
[04711605585347]
Moist Heat or Steam Sterilization
[04711605585347]
Moist Heat or Steam Sterilization
[04711605585347]
Moist Heat or Steam Sterilization
[04711605585347]
Moist Heat or Steam Sterilization
[04711605585347]
Moist Heat or Steam Sterilization
[04711605585347]
Moist Heat or Steam Sterilization
[04711605585347]
Moist Heat or Steam Sterilization
[04711605585347]
Moist Heat or Steam Sterilization
[04711605585347]
Moist Heat or Steam Sterilization
[04711605585347]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 8 |
| Public Version Date | 2019-07-02 |
| Device Publish Date | 2017-07-13 |
| 04711605584531 | UTS Calcar reamer, #00~#7 |
| 04711605584371 | UTS Starter broach, #0~#00 |
| 04711605584159 | Femoral alignment guide |
| 04711605584142 | Straight broach handle |
| 04711605583787 | Pusher |
| 04711605583770 | Modular T-handle |
| 04711605583558 | Alignment rod |
| 04711605582933 | UTS Stem, case #2 |
| 04711605582926 | UTS Stem, case #1 |
| 04711605582421 | UTS Stem case #3 |
| 04711605582414 | UTS Stem, case #2 |
| 04711605582407 | UTS Stem, case #1 |
| 04711605582391 | UTS calcar reamer, #8~#14 |
| 04711605582384 | UTS calcar reamer, #1~#7 |
| 04711605582377 | UTS Neck trial, high offset, #12~#14 |
| 04711605582360 | UTS Neck trial, high offset, #9~#11 |
| 04711605582353 | UTS Neck trial, high offset, #5~#8 |
| 04711605582346 | UTS Neck trial, high offset, #1~#4 |
| 04711605582339 | UTS Neck trial, standard, #12~#14 |
| 04711605582322 | UTS Neck trial, standard, #9~#11 |
| 04711605582315 | UTS Neck trial, standard, #5~#8 |
| 04711605582308 | UTS Neck trial, standard, #1~#4 |
| 04711605582292 | UTS Neck trial, standard, #0~#00 |
| 04711605582285 | Dual-offset broach handle, right |
| 04711605582278 | Dual-offset broach handle, left |
| 04711605582261 | Offset broach handle |
| 04711605582254 | UTS Start broach |
| 04711605582247 | Starter reamer |
| 04711605582230 | Femoral cutting chisel |
| 04711605582223 | UTS Neck resection guide |
| 04711605582216 | Femoral head extractor |
| 04711605582209 | UTS Broach, ML 0mm, #00 |
| 04711605582193 | UTS Broach, ML 0mm, #0 |
| 04711605582186 | UTS Broach, ML 0mm, #14 |
| 04711605582179 | UTS Broach, ML 0mm, #13 |
| 04711605582162 | UTS Broach, ML 0mm, #12 |
| 04711605582155 | UTS Broach, ML 0mm, #11 |
| 04711605582148 | UTS Broach, ML 0mm, #10 |
| 04711605582131 | UTS Broach, ML 0mm, #9 |
| 04711605582124 | UTS Broach, ML 0mm, #8 |
| 04711605582117 | UTS Broach, ML 0mm, #7 |
| 04711605582100 | UTS Broach, ML 0mm, #6 |
| 04711605582094 | UTS Broach, ML 0mm, #5 |
| 04711605582087 | UTS Broach, ML 0mm, #4 |
| 04711605582070 | UTS Broach, ML 0mm, #3 |
| 04711605582063 | UTS Broach, ML 0mm, #2 |
| 04711605582056 | UTS Broach, ML 0mm, #1 |
| 04711605585347 | Femoral head extractor |
| 04719872140504 | Offset broach handle |
| 04719872142089 | Angled broach handle |