| Primary Device ID | B3805FOCC400 |
| NIH Device Record Key | 79b3f660-39a5-4121-97ea-f3d4d5dd065e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LMI OCCLUSION CATHETER |
| Version Model Number | 5FOCC40 |
| Company DUNS | 878198993 |
| Company Name | LUCAS MEDICAL INC |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B3805FOCC400 [Primary] |
| DXE | Catheter, Embolectomy |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B3805FOCC400]
Ethylene Oxide
[B3805FOCC400]
Ethylene Oxide
[B3805FOCC400]
Ethylene Oxide
[B3805FOCC400]
Ethylene Oxide
[B3805FOCC400]
Ethylene Oxide
[B3805FOCC400]
Ethylene Oxide
[B3805FOCC400]
Ethylene Oxide
[B3805FOCC400]
Ethylene Oxide
[B3805FOCC400]
Ethylene Oxide
[B3805FOCC400]
Ethylene Oxide
[B3805FOCC400]
Ethylene Oxide
[B3805FOCC400]
Ethylene Oxide
[B3805FOCC400]
Ethylene Oxide
[B3805FOCC400]
Ethylene Oxide
[B3805FOCC400]
Ethylene Oxide
[B3805FOCC400]
Ethylene Oxide
[B3805FOCC400]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2016-09-02 |
| B3808FOCC400 | 8FOCC40 |
| B3808FOCC230 | 8FOCC23 |
| B3807FOCC400 | 7FOCC40 |
| B3807FOCC230 | 7FOCC23 |
| B3806FOCC400 | 6FOCC40 |
| B3806FOCC230 | 6FOCC23 |
| B3805FOCC400 | 5FOCC40 |
| B3805FOCC230 | 5FOCC23 |
| B3804FOCC400 | 4FOCC40 |
| B3804FOCC230 | 4FOCC23 |
| B3803FOCC400 | 3FOCC40 |
| B3803FOCC230 | 3FOCC23 |