| Primary Device ID | B046WF110080 |
| NIH Device Record Key | caa9bf86-5b24-474b-a8d7-ae2b5c256856 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cancellous Bone Screw |
| Version Model Number | 50mm |
| Catalog Number | WF-1-1008 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B046WF110080 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-01 |
| Device Publish Date | 2019-03-22 |
| B046WF110080 | 50mm x 6.5mm Cancellous Bone Screw |
| B046WF110070 | 45mm x 6.5mm Cancellous Bone Screw |
| B046WF110050 | 35mm x 6.5mm Cancellous Bone Screws |
| B046WF110040 | 30mm x 6.5mm Cancellous Bone Screw |
| B046WF110030 | 25mm x 6.5mm Cancellous Bone Screw |
| B046WF110020 | 20mm x 6.5mm Cancellous Bone Screws |
| B046WF110010 | 15mm x 6.5mm Cancellous Bone Screw |