| Primary Device ID | 07613378196225 |
| NIH Device Record Key | f61ef3fa-cd73-45e1-bea0-83eef9c904c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 862C-CUSTOM ECF2 AD SoftTop UNI °° Black |
| Version Model Number | 320596 |
| Catalog Number | 320596 |
| 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 |
| 00745129331603 - Cflex Reduce Full Leg SM SM SM Tall Left Black | 2025-07-24 Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the aff |
| 07611711872768 - Textile Donning Gloves | 2025-07-24 A device made of natural latex intended to assist patients and caregivers in donning and removing compression stockings and garm |
| 07611711872775 - Textile Donning Gloves | 2025-07-24 A device made of natural latex intended to assist patients and caregivers in donning and removing compression stockings and garm |
| 07611711872782 - Textile Donning Gloves | 2025-07-24 A device made of natural latex intended to assist patients and caregivers in donning and removing compression stockings and garm |
| 07611711872799 - Textile Donning Gloves | 2025-07-24 A device made of natural latex intended to assist patients and caregivers in donning and removing compression stockings and garm |
| 07611711872805 - Textile Donning Gloves | 2025-07-24 A device made of natural latex intended to assist patients and caregivers in donning and removing compression stockings and garm |
| 07613378196225 - 862C-CUSTOM ECF2 AD SoftTop UNI °° Black | 2025-07-21A 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. |
| 07613378196225 - 862C-CUSTOM ECF2 AD SoftTop UNI °° Black | 2025-07-21 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |
| 07613378196232 - 862C-CUSTOM ECF2 AD SensinovaUnisex UNI °° Black | 2025-07-21 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |