| Primary Device ID | B0462204028400 |
| NIH Device Record Key | dc3b7d34-e851-4992-b6c6-a3f98f727cae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Patellar Button |
| Version Model Number | 28/40 |
| Catalog Number | 22-04-02840 |
| Company DUNS | 169289308 |
| Company Name | SIGNAL MEDICAL CORPORATION |
| 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 | true |
| Manufacturing Date | true |
| 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 |
| Phone | 8103647070 |
| vfowler@signalmd.com | |
| Phone | 8103647070 |
| vfowler@signalmd.com | |
| Phone | 8103647070 |
| vfowler@signalmd.com | |
| Phone | 8103647070 |
| vfowler@signalmd.com | |
| Phone | 8103647070 |
| vfowler@signalmd.com | |
| Phone | 8103647070 |
| vfowler@signalmd.com | |
| Phone | 8103647070 |
| vfowler@signalmd.com | |
| Phone | 8103647070 |
| vfowler@signalmd.com | |
| Phone | 8103647070 |
| vfowler@signalmd.com | |
| Phone | 8103647070 |
| vfowler@signalmd.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B0462204028400 [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 | 2019-10-08 |
| Device Publish Date | 2019-09-30 |
| B0462204034550 | Patellar Button 34/55 |
| B0462204032500 | Patellar Button 32/50 |
| B0462204030450 | Patellar Button 30/45 |
| B0462204028400 | Patellar Button 28/40 |