| Primary Device ID | 07630030855306 |
| NIH Device Record Key | da8797ad-00e1-40dc-b0a1-8295d183054b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MyKnee UNI-ST |
| Version Model Number | 4.9330S |
| Company DUNS | 488227125 |
| Company Name | Medacta International SA |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630030855306 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-14 |
| Device Publish Date | 2024-05-06 |
| 07630345774453 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#6-7-8 ST |
| 07630345774446 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#6-7-8 |
| 07630345774439 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#5 ST |
| 07630345774422 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#5 |
| 07630345774415 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#4 ST |
| 07630345774408 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#4 |
| 07630345774392 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#3 ST |
| 07630345774385 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#3 |
| 07630345774378 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#1-2 ST |
| 07630345774361 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#1-2 |
| 07630345774354 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#6-7-8 ST |
| 07630345774347 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#6-7-8 |
| 07630345774330 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#5 ST |
| 07630345774323 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#5 |
| 07630345774316 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#4 ST |
| 07630345774309 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#4 |
| 07630345774293 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#3 ST |
| 07630345774286 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#3 |
| 07630345774279 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#1-2 ST |
| 07630345774262 | MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#1-2 |
| 07630345774255 | MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#6-7-8 ST |
| 07630345774248 | MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#6-7-8 |
| 07630345774231 | MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#5 ST |
| 07630345774224 | MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#5 |
| 07630345774217 | MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#4 ST |
| 07630345774200 | MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#4 |
| 07630345774194 | MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#3 ST |
| 07630345774187 | MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#3 |
| 07630345774170 | MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#1-2 ST |
| 07630345774163 | MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#1-2 |
| 07630345774156 | MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#6-7-8 ST |
| 07630345774149 | MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#6-7-8 |
| 07630345774132 | MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#5 ST |
| 07630345774125 | MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#5 |
| 07630345774118 | MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#4 ST |
| 07630345774101 | MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#4 |
| 07630345774095 | MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#3 ST |
| 07630345774088 | MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#3 |
| 07630345774071 | MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#1-2 ST |
| 07630345774064 | MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#1-2 |
| 07630030855306 | MyKnee UNI Tibia Bone Model LM - STERILE |
| 07630030855344 | MyKnee UNI Tibia Bone Model RM - STERILE |