| Primary Device ID | 05055343884805 |
| NIH Device Record Key | f68f6e0d-57ce-41e1-b95c-6a02a81ff365 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Unity Total Knee System |
| Version Model Number | 123.369.77 |
| Catalog Number | 123.369.77 |
| Company DUNS | 295437313 |
| Company Name | CORIN LTD |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 | +441285659866 |
| lucinda.gerber@coringroup.com | |
| Phone | +441285659866 |
| lucinda.gerber@coringroup.com | |
| Phone | +441285659866 |
| lucinda.gerber@coringroup.com | |
| Phone | +441285659866 |
| lucinda.gerber@coringroup.com | |
| Phone | +441285659866 |
| lucinda.gerber@coringroup.com | |
| Phone | +441285659866 |
| lucinda.gerber@coringroup.com | |
| Phone | +441285659866 |
| lucinda.gerber@coringroup.com | |
| Phone | +441285659866 |
| lucinda.gerber@coringroup.com | |
| Phone | +441285659866 |
| lucinda.gerber@coringroup.com | |
| Phone | +441285659866 |
| lucinda.gerber@coringroup.com | |
| Phone | +441285659866 |
| lucinda.gerber@coringroup.com | |
| Phone | +441285659866 |
| lucinda.gerber@coringroup.com | |
| Phone | +441285659866 |
| lucinda.gerber@coringroup.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055343884805 [Primary] |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05055343884805]
Moist Heat or Steam Sterilization
[05055343884805]
Moist Heat or Steam Sterilization
[05055343884805]
Moist Heat or Steam Sterilization
[05055343884805]
Moist Heat or Steam Sterilization
[05055343884805]
Moist Heat or Steam Sterilization
[05055343884805]
Moist Heat or Steam Sterilization
[05055343884805]
Moist Heat or Steam Sterilization
[05055343884805]
Moist Heat or Steam Sterilization
[05055343884805]
Moist Heat or Steam Sterilization
[05055343884805]
Moist Heat or Steam Sterilization
[05055343884805]
Moist Heat or Steam Sterilization
[05055343884805]
Moist Heat or Steam Sterilization
[05055343884805]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2016-08-17 |
| 05056139233760 | Hole Saw Guide |
| 05056139233753 | Hole Saw |
| 05056139233746 | Threaded Collarless Pin Long |
| 05056139233739 | Unity ASC IM Rod |
| 05056139233722 | Universal Impactor |
| 05056139233715 | Extraction Tool |
| 05056139233708 | Unity ASC Modular Handle |
| 05056139233227 | Unity ASC Tibial Insert Trials Size 7 to 9 9-14mm Thick |
| 05056139233210 | Unity ASC Tibial Insert Trials Size 7 to 9 9-14mm Thick |
| 05056139233203 | Unity ASC Tibial Insert Trials Size 7 to 9 9-14mm Thick |
| 05056139233197 | Unity ASC Tibial Insert Trials Size 7 to 9 9-14mm Thick |
| 05056139233180 | Unity ASC Tibial Insert Trials Size 7 to 9 9-14mm Thick |
| 05056139233173 | Unity ASC Tibial Insert Trials Size 4 to 6 9-14mm Thick |
| 05056139233166 | Unity ASC Tibial Insert Trials Size 4 to 6 9-14mm Thick |
| 05056139233159 | Unity ASC Tibial Insert Trials Size 4 to 6 9-14mm Thick |
| 05056139233142 | Unity ASC Tibial Insert Trials Size 4 to 6 9-14mm Thick |
| 05056139233128 | Unity ASC Size 8 Tibial Template Trial |
| 05056139233111 | Unity ASC Size 7 Tibial Template Trial |
| 05056139233104 | Unity ASC Size 6 Tibial Template Trial |
| 05056139233098 | Unity ASC Size 5 Tibial Template Trial |
| 05056139233081 | Unity ASC Size 4 Tibial Template Trial |
| 05056139233036 | Unity ASC Tibial Insert Trials Size 4 to 6 9-14mm Thick |
| 05056139232978 | Unity ASC Femoral PS Saw Resection Guide Std |
| 05056139232961 | Unity ASC Femoral PS Insert Macro |
| 05056139232879 | Patella Caliper |
| 05056139232688 | Down Rod |
| 05056139232657 | Tibial Stylus |
| 05056139232640 | 3in1 Block |
| 05056139232633 | Ankle Clamp & ML Guide |
| 05056139232626 | Up Rod |
| 05056139232596 | Pin Puller |
| 05056139232589 | Femoral Introducer Impactor Head |
| 05056139232572 | Distal Resection Guide |
| 05056139232565 | Femoral Introducer |
| 05056139232558 | Patella Drill Guide Dome Sz 4 & 5 |
| 05056139232541 | Patella Drill Guide Dome Sz 1 to 3 |
| 05056139232534 | Patella Drill Guide Offset Dome Sz 3 & 4 |
| 05056139232527 | Patella Drill Guide Offset Dome Sz 1 & 2 |
| 05056139232510 | Patella Cement Clamp |
| 05056139232503 | Patella Clamp |
| 05056139232237 | Tibial Cutting Block Right |
| 05056139232220 | Tibial Cutting Block Left |
| 05056139231568 | Femoral / Tibial Augment Screw 5 mm |
| 05056139231476 | Torque Indicator |
| 05056139231469 | 2.5 m Allen Key |
| 05056139231360 | Tibial Augment Trial RL-LM Size 9 |
| 05056139231353 | Tibial Augment Trial RL-LM Size 8 |
| 05056139231346 | Tibial Augment Trial RL-LM Size 7 |
| 05056139231339 | Tibial Augment Trial RL-LM Size 6 |
| 05056139231322 | Tibial Augment Trial RL-LM Size 5 |