| Primary Device ID | B046WZ110420 |
| NIH Device Record Key | aeb51564-6e92-4b50-8f3e-7e5ebd8df34a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Uni Tibial Insert |
| Version Model Number | 2x8 |
| Catalog Number | WZ-1-1042 |
| 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 | 810-364-7070 |
| jgorney@signalmd.com | |
| Phone | 810-364-7070 |
| jgorney@signalmd.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B046WZ110420 [Primary] |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-05-20 |
| B046WZ110450 | Uni Tibial Insert 5x8 |
| B046WZ110440 | Uni Tibial Insert 4x8 |
| B046WZ110430 | Uni Tibial Insert 3x8 |
| B046WZ110420 | Uni Tibial Insert 2x8 |
| B046WZ110410 | Uni Tibial Insert 1x8 |
| B046WZ110390 | Uni Tibial Insert 5x14 |
| B046WZ110380 | Uni Tibial Insert 5x12 |
| B046WZ110370 | Uni Tibial Insert 5x10 |
| B046WZ110350 | Uni Tibial Insert 4x14 |
| B046WZ110340 | Uni Tibial Insert 4x12 |
| B046WZ110330 | Uni Tibial Insert 4x10 |
| B046WZ110310 | Uni Tibial Insert 3x14 |
| B046WZ110300 | Uni Tibial Insert 3x12 |
| B046WZ110290 | Uni Tibial Insert 3x10 |
| B046WZ110270 | Uni Tibial Insert 2x14 |
| B046WZ110260 | Uni Tibial Insert 2x12 |
| B046WZ110250 | Uni Tibial Insert 2x10 |
| B046WZ110230 | Uni Tibial Insert 1x14 |
| B046WZ110220 | Uni Tibial Insert 1x12 |
| B046WZ110210 | Uni Tibial Insert 1x10 |