Primary Device ID | 04547898737503 |
NIH Device Record Key | afe6677c-2e57-41d2-b5f6-f2bb731d67a6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Initia Total Hip System |
Version Model Number | TJ41393-44 |
Catalog Number | TJ41393-44 |
Company DUNS | 694697025 |
Company Name | KYOCERA CORPORATION |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
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 | false |
Serial Number | true |
Manufacturing Date | false |
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 | 909-557-2360 |
kmti.info@kyocera.com | |
Phone | 909-557-2360 |
kmti.info@kyocera.com | |
Phone | 909-557-2360 |
kmti.info@kyocera.com | |
Phone | 909-557-2360 |
kmti.info@kyocera.com | |
Phone | 909-557-2360 |
kmti.info@kyocera.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04547898737503 [Primary] |
LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
Steralize Prior To Use | true |
Device Is Sterile | false |
[04547898737503]
Moist Heat or Steam Sterilization
[04547898737503]
Moist Heat or Steam Sterilization
[04547898737503]
Moist Heat or Steam Sterilization
[04547898737503]
Moist Heat or Steam Sterilization
[04547898737503]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-03-18 |
Device Publish Date | 2017-02-21 |
04547898737541 | STD-HO LINER TRIAL 28-44 |
04547898737534 | STD-HO LINER TRIAL 40-72/74 |
04547898737527 | STD-HO LINER TRIAL 36-72/74 |
04547898737510 | STD-HO LINER TRIAL 32-72/74 |
04547898737503 | STD-HO LINER TRIAL 40-66/68/70 |
04547898737497 | STD-HO LINER TRIAL 36-66/68/70 |
04547898737480 | STD-HO LINER TRIAL 32-66/68/70 |
04547898737473 | STD-HO LINER TRIAL 40-60/62/64 |
04547898737466 | STD-HO LINER TRIAL 36-60/62/64 |
04547898737459 | STD-HO LINER TRIAL 32-60/62/64 |
04547898737442 | STD-HO LINER TRIAL 40-56/58 |
04547898737435 | STD-HO LINER TRIAL 36-56/58 |
04547898737428 | STD-HO LINER TRIAL 32-56/58 |
04547898737411 | STD-HO LINER TRIAL 36-52/54 |
04547898737404 | STD-HO LINER TRIAL 32-52/54 |
04547898737398 | STD-HO LINER TRIAL 36-50 |
04547898737381 | STD-HO LINER TRIAL 32-50 |
04547898737374 | STD-HO LINER TRIAL 28-50 |
04547898737367 | STD-HO LINER TRIAL 32-48 |
04547898737350 | STD-HO LINER TRIAL 28-48 |
04547898737343 | STD-HO LINER TRIAL 32-46 |
04547898737336 | STD-HO LINER TRIAL 28-46 |
04547898737312 | STD LINER TRIAL 28-44 |
04547898737305 | STD LINER TRIAL 40-72/74 |
04547898737299 | STD LINER TRIAL 36-72/74 |
04547898737282 | STD LINER TRIAL 32-72/74 |
04547898737275 | STD LINER TRIAL 40-66/68/70 |
04547898737268 | STD LINER TRIAL 36-66/68/70 |
04547898737251 | STD LINER TRIAL 32-66/68/70 |
04547898737244 | STD LINER TRIAL 40-60/62/64 |
04547898737237 | STD LINER TRIAL 36-60/62/64 |
04547898737220 | STD LINER TRIAL 32-60/62/64 |
04547898737213 | STD LINER TRIAL 40-56/58 |
04547898737206 | STD LINER TRIAL 36-56/58 |
04547898737190 | STD LINER TRIAL 32-56/58 |
04547898737183 | STD LINER TRIAL 36-52/54 |
04547898737176 | STD LINER TRIAL 32-52/54 |
04547898737169 | STD LINER TRIAL 36-50 |
04547898737152 | STD LINER TRIAL 32-50 |
04547898737145 | STD LINER TRIAL 28-50 |
04547898737138 | STD LINER TRIAL 32-48 |
04547898737121 | STD LINER TRIAL 28-48 |
04547898737114 | STD LINER TRIAL 32-46 |
04547898737107 | STD LINER TRIAL 28-46 |
04547898736933 | INITIA BROACH 10 |
04547898736926 | INITIA BROACH 9 |
04547898736919 | MALLET |
04547898736902 | FEMORAL BROACH TRAY |
04547898736513 | MX-HO LINER TRIAL 28-44 |
04547898736506 | MX-HO LINER TRIAL 28-50 |