| Primary Device ID | 00840286843942 |
| NIH Device Record Key | 89ff1b21-e15a-4aa1-abe1-448f5c5d6650 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UniSyn Hip System |
| Version Model Number | 4410-20020-A |
| Catalog Number | 4410-20020-A |
| Company DUNS | 085976260 |
| Company Name | Shalby Advanced Technologies, Inc. |
| 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 | 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 | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.com | |
| Phone | +1(916)355-7100 |
| khansen@consensusortho.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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00840286843942 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840286843942]
Moist Heat or Steam Sterilization
[00840286843942]
Moist Heat or Steam Sterilization
[00840286843942]
Moist Heat or Steam Sterilization
[00840286843942]
Moist Heat or Steam Sterilization
[00840286843942]
Moist Heat or Steam Sterilization
[00840286843942]
Moist Heat or Steam Sterilization
[00840286843942]
Moist Heat or Steam Sterilization
[00840286843942]
Moist Heat or Steam Sterilization
[00840286843942]
Moist Heat or Steam Sterilization
[00840286843942]
Moist Heat or Steam Sterilization
[00840286843942]
Moist Heat or Steam Sterilization
[00840286843942]
Moist Heat or Steam Sterilization
[00840286843942]
Moist Heat or Steam Sterilization
[00840286843942]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-22 |
| Device Publish Date | 2025-05-14 |
| 00840286837903 | Body, Calcar, Cementless, PC, HA Coated, 30mm |
| 00840286837897 | Body, Calcar, Cementless, PC, HA Coated, 28mm |
| 00840286837880 | Body, Calcar, Cementless, PC, HA Coated, 26mm |
| 00840286837873 | Body, Calcar, Cementless, PC, HA Coated, 24mm |
| 00840286837866 | Body, Calcar, Cementless, PC, HA Coated, 22mm |
| 00840286837859 | Body, Calcar, Cementless, PC, Plasma, 30mm |
| 00840286837842 | Body, Calcar, Cementless, PC, Plasma, 30mm |
| 00840286837835 | Body, Calcar, Cementless, PC, Plasma, 28mm |
| 00840286837828 | Body, Calcar, Cementless, PC, Plasma, 28mm |
| 00840286837811 | Body, Calcar, Cementless, PC, Plasma, 26mm |
| 00840286837804 | Body, Calcar, Cementless, PC, Plasma, 26mm |
| 00840286837798 | Body, Calcar, Cementless, PC, Plasma, 24mm |
| 00840286837781 | Body, Calcar, Cementless, PC, Plasma, 24mm |
| 00840286837774 | Body, Calcar, Cementless, PC, Plasma, 22mm |
| 00840286837767 | Body, Calcar, Cementless, PC, Plasma, 22mm |
| 00840286837750 | Body, Calcar, Cementless, NP, Grit Blast, 30mm |
| 00840286837743 | Body, Calcar, Cementless, NP, Grit Blast, 28mm |
| 00840286837736 | Body, Calcar, Cementless, NP, Grit Blast, 26mm |
| 00840286837729 | Body, Calcar, Cementless, NP, Grit Blast, 24mm |
| 00840286837712 | Body, Calcar, Cementless, NP, Grit Blast, 22mm |
| 00840286837705 | Body, Standard, Cementless, PC, HA/Plasma, 32mm, 38mm |
| 00840286837699 | Body, Standard, Cementless, PC, HA/Plasma, 32mm, 34mm |
| 00840286837682 | Body, Standard, Cementless, PC, HA/Plasma, 32mm, 30mm |
| 00840286837675 | Body, Standard, Cementless, PC, HA/Plasma, 30mm, 38mm |
| 00840286837668 | Body, Standard, Cementless, PC, HA/Plasma, 30mm, 34mm |
| 00840286837651 | Body, Standard, Cementless, PC, HA/Plasma, 30mm, 30mm |
| 00840286837644 | Body, Standard, Cementless, PC, HA/Plasma, 30mm, 26mm |
| 00840286837637 | Body, Standard, Cementless, PC, HA/Plasma, 28mm, 34mm |
| 00840286837620 | Body, Standard, Cementless, PC, HA/Plasma, 28mm, 30mm |
| 00840286837613 | Body, Standard, Cementless, PC, HA/Plasma, 28mm, 26mm |
| 00840286837606 | Body, Standard, Cementless, PC, HA/Plasma, 26mm, 34mm |
| 00840286837590 | Body, Standard, Cementless, PC, HA/Plasma, 26mm, 30mm |
| 00840286837583 | Body, Standard, Cementless, PC, HA/Plasma, 26mm, 26mm |
| 00840286837576 | Body, Standard, Cementless, PC, HA/Plasma, 26mm, 22mm |
| 00840286837569 | Body, Standard, Cementless, PC, HA/Plasma, 24mm, 34mm |
| 00840286837552 | Body, Standard, Cementless, PC, HA/Plasma, 24mm, 30mm |
| 00840286837545 | Body, Standard, Cementless, PC, HA/Plasma, 24mm, 26mm |
| 00840286837538 | Body, Standard, Cementless, PC, HA/Plasma, 24mm, 22mm |
| 00840286837521 | Body, Standard, Cementless, PC, HA/Plasma, 22mm, 30mm |
| 00840286837514 | Body, Standard, Cementless, PC, HA/Plasma, 22mm, 26mm |
| 00840286837507 | Body, Standard, Cementless, PC, HA/Plasma, 22mm, 22mm |
| 00840286837491 | Body, Standard, Cementless, PC, Plasma, 32mm, 38mm |
| 00840286837484 | Body, Standard, Cementless, PC, Plasma, 32mm, 34mm |
| 00840286837477 | Body, Standard, Cementless, PC, Plasma, 32mm, 30mm |
| 00840286837460 | Body, Standard, Cementless, PC, Plasma, 30mm, 38mm |
| 00840286837453 | Body, Standard, Cementless, PC, Plasma, 30mm, 34mm |
| 00840286837446 | Body, Standard, Cementless, PC, Plasma, 30mm, 34mm |
| 00840286837439 | Body, Standard, Cementless, PC, Plasma, 30mm, 30mm |
| 00840286837422 | Body, Standard, Cementless, PC, Plasma, 30mm, 30mm |
| 00840286837415 | Body, Standard, Cementless, PC, Plasma, 30mm, 26mm |