FDA.reportPublic FDA data

862N-CUSTOM ECF2 AF Quadrinova UNI °° Grey

Primary DI
07613378197772
Brand
862N-CUSTOM ECF2 AF Quadrinova UNI °° Grey
Company
SIGVARIS INC
Model
320441
Catalog number
320441
Device description
A 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.
Published
2026-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQLStocking, Medical Support (For General Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613378197772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613378197772076133781977727613378197772

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, single-useA garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)322-7744sigvariscares@sigvaris.com

Regulatory Flags#

DUNS number
189738719
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613378196157862W-CUSTOM ECF2 AGT WaistAttachment UNI °° Black3206033206032026-05-18
07613378196164862T-CUSTOM ECF2 AG SoftTop UNI °° Black3206023206022026-05-18
07613378196553862T-CUSTOM ECF2 AG SoftTop UNI Black3205633205632026-05-18
07613378196560862N-CUSTOM ECF2 AG SensinovaUnisex UNI Black3205623205622026-05-18
07613378196942862T-CUSTOM ECF2 AG SoftTop UNI °° Caramel3205243205242026-05-18
07613378197338862T-CUSTOM ECF2 AG SoftTop UNI Caramel3204853204852026-05-18
07613378197345862N-CUSTOM ECF2 AG SensinovaUnisex UNI Caramel3204843204842026-05-18
07613378197727862T-CUSTOM ECF2 AG SoftTop UNI °° Grey3204463204462026-05-18
07613378198113862T-CUSTOM ECF2 AG SoftTop UNI Grey3204073204072026-05-18
07613378198120862N-CUSTOM ECF2 AG SensinovaUnisex UNI Grey3204063204062026-05-18
07613378198502862T-CUSTOM ECF2 AG SoftTop UNI °° Savanna3203683203682026-05-18
07613378198892862T-CUSTOM ECF2 AG SoftTop UNI Savanna3203293203292026-05-18
07613378198908862N-CUSTOM ECF2 AG SensinovaUnisex UNI Savanna3203283203282026-05-18
07613378199288862T-CUSTOM ECF2 AG SoftTop UNI °° Skin3202903202902026-05-18
07613378199677862T-CUSTOM ECF2 AG SoftTop UNI Skin3202513202512026-05-18
07613378199684862N-CUSTOM ECF2 AG SensinovaUnisex UNI Skin3202503202502026-05-18
07613378277504862N-CUSTOM ECF2 AG SensinovaUnisex UNI marine3555233555232026-05-18
07613378277511862T-CUSTOM ECF2 AG SoftTop UNI marine3555243555242026-05-18
07613378277900862T-CUSTOM ECF2 AG SoftTop UNI °° marine3555633555632026-05-18
00745129334581422C Motion Thermo Wool 20-30mmHG U LL Denim MSTRP422CLL39 or 22061422CLL392026-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4200211Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201011Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201031Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201041Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201061Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4202011Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4202021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203001Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203011Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203031Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203041Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203051Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203061Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203071Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203081Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203091Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203311Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203321Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203331Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203341Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203361Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203371Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203381Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203391Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203411Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203421Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4204001Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4204011Compression StockingGottfried Medical, Inc.FQL2026-06-04