862P-CUSTOM ECF2 AT SoftTop MEN Savanna

Primary DI
07613378198861
Brand
862P-CUSTOM ECF2 AT SoftTop MEN Savanna
Company
SIGVARIS INC
Model
320332
Catalog number
320332
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
2026-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
07613378198861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613378198861076133781988617613378198861

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, reusableA 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 reusable device.

Device Sizes#

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

Contacts#

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

Regulatory Flags#

DUNS number
189738719
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00745129335069Envelo Arm Wrap Small Short Beige3111-ARS or 221093111-ARS2026-07-22
00745129335076Envelo Arm Wrap Small Regular Beige3111-ARR or 221103111-ARR2026-07-22
00745129335083Envelo Arm Wrap Small Long Beige3111-ARL or 221113111-ARL2026-07-22
00745129335090Envelo Arm Wrap Max Small Short Beige3111-AMS or 221123111-AMS2026-07-22
00745129335106Envelo Arm Wrap Max Small Regular Beige3111-AMR or 221133111-AMR2026-07-22
00745129335113Envelo Arm Wrap Max Small Long Beige3111-AML or 221143111-AML2026-07-22
00745129335120Envelo Arm Wrap Medium Short Beige3112-ARS or 221153112-ARS2026-07-22
00745129335137Envelo Arm Wrap Medium Regular Beige3112-ARR or 221163112-ARR2026-07-22
00745129335144Envelo Arm Wrap Medium Long Beige3112-ARL or 221173112-ARL2026-07-22
00745129335151Envelo Arm Wrap Max Medium Short Beige3112-AMS or 221183112-AMS2026-07-22
00745129335168Envelo Arm Wrap Max Medium Regular Beige3112-AMR or 221193112-AMR2026-07-22
00745129335175Envelo Arm Wrap Max Medium Long Beige3112-AML or 221203112-AML2026-07-22
00745129335182Envelo Arm Wrap Large Short Beige3113-ARS or 221213113-ARS2026-07-22
07613378196126862P-CUSTOM ECF2 AT1L SoftTop FEM °° Black3206063206062026-07-22
07613378196522862P-CUSTOM ECF2 AT SoftTop MEN Black3205663205662026-07-22
07613378196911862P-CUSTOM ECF2 AT SoftTop MEN °° Caramel3205273205272026-07-22
07613378197307862P-CUSTOM ECF2 AT SoftTop MEN Caramel3204883204882026-07-22
07613378197697862P-CUSTOM ECF2 AT SoftTop MEN °° Grey3204493204492026-07-22
07613378198083862P-CUSTOM ECF2 AT SoftTop MEN Grey3204103204102026-07-22
07613378198472862P-CUSTOM ECF2 AT SoftTop MEN °° Savanna3203713203712026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613378196126862P-CUSTOM ECF2 AT1L SoftTop FEM °° BlackSIGVARIS INCFQL2026-07-22
07613378196522862P-CUSTOM ECF2 AT SoftTop MEN BlackSIGVARIS INCFQL2026-07-22
07613378196911862P-CUSTOM ECF2 AT SoftTop MEN °° CaramelSIGVARIS INCFQL2026-07-22
07613378197307862P-CUSTOM ECF2 AT SoftTop MEN CaramelSIGVARIS INCFQL2026-07-22
07613378197697862P-CUSTOM ECF2 AT SoftTop MEN °° GreySIGVARIS INCFQL2026-07-22
07613378198083862P-CUSTOM ECF2 AT SoftTop MEN GreySIGVARIS INCFQL2026-07-22
07613378198472862P-CUSTOM ECF2 AT SoftTop MEN °° SavannaSIGVARIS INCFQL2026-07-22
07613378199257862P-CUSTOM ECF2 AT SoftTop MEN °° SkinSIGVARIS INCFQL2026-07-22
07613378199646862P-CUSTOM ECF2 AT SoftTop MEN SkinSIGVARIS INCFQL2026-07-22
07613378277542862P-CUSTOM ECF2 AT SoftTop MEN marineSIGVARIS INCFQL2026-07-22
07613378277931862P-CUSTOM ECF2 AT SoftTop MEN °° marineSIGVARIS INCFQL2026-07-22
07613378196133862P-CUSTOM ECF2 AT SoftTop MEN °° BlackSIGVARIS INCFQL2026-07-20
07613378196539862P-CUSTOM ECF2 AT SoftTop FEM BlackSIGVARIS INCFQL2026-07-20
07613378196928862P-CUSTOM ECF2 AT SoftTop FEM °° CaramelSIGVARIS INCFQL2026-07-20
07613378197314862P-CUSTOM ECF2 AT SoftTop FEM CaramelSIGVARIS INCFQL2026-07-20
07613378197703862P-CUSTOM ECF2 AT SoftTop FEM °° GreySIGVARIS INCFQL2026-07-20
07613378198090862P-CUSTOM ECF2 AT SoftTop FEM GreySIGVARIS INCFQL2026-07-20
07613378198489862P-CUSTOM ECF2 AT SoftTop FEM °° SavannaSIGVARIS INCFQL2026-07-20
07613378198878862P-CUSTOM ECF2 AT SoftTop FEM SavannaSIGVARIS INCFQL2026-07-20
07613378199264862P-CUSTOM ECF2 AT SoftTop FEM °° SkinSIGVARIS INCFQL2026-07-20
07613378199653862P-CUSTOM ECF2 AT SoftTop FEM SkinSIGVARIS INCFQL2026-07-20
07613378277535862P-CUSTOM ECF2 AT SoftTop FEM marineSIGVARIS INCFQL2026-07-20
07613378277924862P-CUSTOM ECF2 AT SoftTop FEM °° marineSIGVARIS INCFQL2026-07-20
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