| Primary Device ID | 15711055004333 |
| NIH Device Record Key | 9ffa0a90-2617-4313-9674-8f55345172a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | D*Clot® HD Rotational Thrombectomy System |
| Version Model Number | D*Clot® HD 6Fx65CM |
| Catalog Number | T10106065 |
| Company DUNS | 308951313 |
| Company Name | Mermaid Medical A/S |
| 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 |
| Phone | +4547108570 |
| customer@mermaidmedical.com |
| Catheter Length | 65 Centimeter |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05711055004336 [Package] Package: Shelfbox [1 Units] In Commercial Distribution |
| GS1 | 15711055004333 [Primary] |
| DXE | Catheter, Embolectomy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-24 |
| Device Publish Date | 2020-03-16 |
| 15711055004333 | The D*Clot® HD Rotational Thrombectomy Catheter is indicated for mechanical declotting of nativ |
| 15711055004326 | The D*Clot® HD Rotational Thrombectomy Catheter is indicated for mechanical declotting of nativ |