| Primary Device ID | B090MT101 |
| NIH Device Record Key | b0866c5f-cd01-45f0-82b9-ccd0b3ed277e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Control 10T Mechanical Thrombectomy Filter |
| Version Model Number | MT10 |
| Catalog Number | MT10 |
| Company DUNS | 017535668 |
| Company Name | ZIEN MEDICAL TECHNOLOGIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B090MT100 [Primary] |
| HIBCC | B090MT101 [Package] Contains: B090MT100 Package: Shelf Carton [5 Units] In Commercial Distribution |
| HIBCC | B090MT102 [Package] Package: Shipper [2 Units] In Commercial Distribution |
| BYY | Tube, Aspirating, Flexible, Connecting |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-01 |
| Device Publish Date | 2022-10-24 |
| B090MT101 | The Control 10T Mechanical Thrombectomy Filter is designed to connect a catheter with a female l |
| B090ASP10391 | The Control 10T Mechanical Thrombectomy Filter is designed to connect a catheter with a female l |