| Primary Device ID | 07613378197123 |
| NIH Device Record Key | 55c337ab-cea1-468d-91e2-4e75d653080d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 861P-CUSTOM ECF1 AT SoftTop MEN °° Caramel |
| Version Model Number | 320506 |
| Catalog Number | 320506 |
| Company DUNS | 189738719 |
| Company Name | SIGVARIS 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| 07613378196348 - 861P-CUSTOM ECF1 AT SoftTop MEN °° Black | 2025-04-07 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |
| 07613378196355 - 861P-CUSTOM ECF1 AT SoftTop FEM °° Black | 2025-04-07 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |
| 07613378196706 - 861P-CUSTOM ECF1 AT SoftTop MEN Black | 2025-04-07 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |
| 07613378196713 - 861P-CUSTOM ECF1 AT SoftTop FEM Black | 2025-04-07 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |
| 07613378196720 - 861W-CUSTOM ECF1 AGT WaistAttachment UNI Black | 2025-04-07 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |
| 07613378197123 - 861P-CUSTOM ECF1 AT SoftTop MEN °° Caramel | 2025-04-07A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device. |
| 07613378197123 - 861P-CUSTOM ECF1 AT SoftTop MEN °° Caramel | 2025-04-07 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |
| 07613378197130 - 861P-CUSTOM ECF1 AT SoftTop FEM °° Caramel | 2025-04-07 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |
| 07613378197482 - 861P-CUSTOM ECF1 AT SoftTop MEN Caramel | 2025-04-07 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |