Optiform Flex

Primary DI
07613378093463
Brand
Optiform Flex
Company
SIGVARIS INC
Model
OF2B1G
Catalog number
OF2B1G
Device description
Optiform Flex B1G CCL2. A custom sewn device from a flat knit compression template in the form of a tube intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema; it is neither a strip/roll binder, glove, sock/stocking, nor tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex); it does not include antimicrobial features. This is a reusable device.
Published
2024-11-11
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
07613378093463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613378093463076133780934637613378093463

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure tubular garmentA device in the form of a tube intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema; it is neither a strip/roll binder, glove, sock/stocking, nor tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex); it does not include antimicrobial features. This is a reusable 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
Serial number
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
07613378196157862W-CUSTOM ECF2 AGT WaistAttachment UNI °° BlackSIGVARIS INCFQL2026-05-18
07613378196164862T-CUSTOM ECF2 AG SoftTop UNI °° BlackSIGVARIS INCFQL2026-05-18
07613378196553862T-CUSTOM ECF2 AG SoftTop UNI BlackSIGVARIS INCFQL2026-05-18
07613378196560862N-CUSTOM ECF2 AG SensinovaUnisex UNI BlackSIGVARIS INCFQL2026-05-18
07613378196942862T-CUSTOM ECF2 AG SoftTop UNI °° CaramelSIGVARIS INCFQL2026-05-18
07613378197338862T-CUSTOM ECF2 AG SoftTop UNI CaramelSIGVARIS INCFQL2026-05-18
07613378197345862N-CUSTOM ECF2 AG SensinovaUnisex UNI CaramelSIGVARIS INCFQL2026-05-18
07613378197727862T-CUSTOM ECF2 AG SoftTop UNI °° GreySIGVARIS INCFQL2026-05-18
07613378198113862T-CUSTOM ECF2 AG SoftTop UNI GreySIGVARIS INCFQL2026-05-18
07613378198120862N-CUSTOM ECF2 AG SensinovaUnisex UNI GreySIGVARIS INCFQL2026-05-18
07613378198502862T-CUSTOM ECF2 AG SoftTop UNI °° SavannaSIGVARIS INCFQL2026-05-18
07613378198892862T-CUSTOM ECF2 AG SoftTop UNI SavannaSIGVARIS INCFQL2026-05-18
07613378198908862N-CUSTOM ECF2 AG SensinovaUnisex UNI SavannaSIGVARIS INCFQL2026-05-18
07613378199288862T-CUSTOM ECF2 AG SoftTop UNI °° SkinSIGVARIS INCFQL2026-05-18
07613378199677862T-CUSTOM ECF2 AG SoftTop UNI SkinSIGVARIS INCFQL2026-05-18
07613378199684862N-CUSTOM ECF2 AG SensinovaUnisex UNI SkinSIGVARIS INCFQL2026-05-18
07613378277504862N-CUSTOM ECF2 AG SensinovaUnisex UNI marineSIGVARIS INCFQL2026-05-18
07613378277511862T-CUSTOM ECF2 AG SoftTop UNI marineSIGVARIS INCFQL2026-05-18
07613378277900862T-CUSTOM ECF2 AG SoftTop UNI °° marineSIGVARIS INCFQL2026-05-18
08300496033981SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
08300496071099SOLIDEACALZIFICIO PINELLI SRLFQL2026-05-15
07613378199295862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° SkinSIGVARIS INCFQL2026-03-25
07613378196195862T-CUSTOM ECF2 AF SoftTop UNI °° BlackSIGVARIS INCFQL2026-03-18
07613378196584862T-CUSTOM ECF2 AF SoftTop UNI BlackSIGVARIS INCFQL2026-03-18
07613378196591862N-CUSTOM ECF2 AF SensinovaUnisex UNI BlackSIGVARIS INCFQL2026-03-18
07613378196973862T-CUSTOM ECF2 AF SoftTop UNI °° CaramelSIGVARIS INCFQL2026-03-18
07613378196980862N-CUSTOM ECF2 AF SensinovaUnisex UNI °° CaramelSIGVARIS INCFQL2026-03-18
07613378197369862T-CUSTOM ECF2 AF SoftTop UNI CaramelSIGVARIS INCFQL2026-03-18
07613378197376862N-CUSTOM ECF2 AF SensinovaUnisex UNI CaramelSIGVARIS INCFQL2026-03-18
07613378197758862T-CUSTOM ECF2 AF SoftTop UNI °° GreySIGVARIS INCFQL2026-03-18