| Primary Device ID | 04719872142072 | 
| NIH Device Record Key | 9388051d-ee28-497c-be1c-91353ca98aaa | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | UTS Hip Stem | 
| Version Model Number | 9116-1502-TC | 
| 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 | |
| Phone | +886229294567 | 
| service@uoc.com.tw | |
| Phone | +886229294567 | 
| service@uoc.com.tw | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04719872142072 [Primary] | 
| LXH | Orthopedic Manual Surgical Instrument | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[04719872142072]
Moist Heat or Steam Sterilization
[04719872142072]
Moist Heat or Steam Sterilization
[04719872142072]
Moist Heat or Steam Sterilization
[04719872142072]
Moist Heat or Steam Sterilization
[04719872142072]
Moist Heat or Steam Sterilization
[04719872142072]
Moist Heat or Steam Sterilization
[04719872142072]
Moist Heat or Steam Sterilization
[04719872142072]
Moist Heat or Steam Sterilization
[04719872142072]
Moist Heat or Steam Sterilization
[04719872142072]
Moist Heat or Steam Sterilization
[04719872142072]
Moist Heat or Steam Sterilization
[04719872142072]
Moist Heat or Steam Sterilization
[04719872142072]
Moist Heat or Steam Sterilization
[04719872142072]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-07-31 | 
| Device Publish Date | 2020-07-23 | 
| 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 |