| Primary Device ID | B046BIO110120 |
| NIH Device Record Key | 7b51c1aa-9d2d-4cb4-aada-ac4438fe027a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoCr Low Profile Cable System |
| Version Model Number | 1.5mm Cable |
| Catalog Number | BIO11012 |
| 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 | 1-810-364-7070 |
| jgorney@signalmd.com | |
| Phone | 1-810-364-7070 |
| jgorney@signalmd.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B046BIO110120 [Primary] |
| JDQ | Cerclage, Fixation |
| 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 | 2016-01-12 |
| B046BIO110930 - Straight Osteotome | 2023-05-02 Straight Osteotome 1/2" |
| B046BIO110440 - Knee Osteogator | 2023-03-22 Knee Osteogator |
| B046BIO110830 - PCL Retractor | 2023-03-01 PCL Retractor |
| B046BIO11081 - Femoral Belt | 2022-06-27 Femoral Belt |
| B046BIO110430 - Alligator Rongeur | 2022-05-20 9" Alligator Rongeur |
| B046BIO11082 - Tibial Belt | 2022-05-20 Tibial Belt |
| B046BIO110840 - Lateral Retractor | 2022-05-20 Lateral Retractor |
| B046BIO110910 - Mallet Tip - Teflon | 2022-04-01 Mallet Tip - Teflon |