FDA.reportPublic FDA data

Extensor Medium/Large

Primary DI
00745129164720
Brand
Extensor Medium/Large
Company
SIGVARIS INC
Model
584
Catalog number
584EXML
Device description
A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose).
Published
2016-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)
FQLStocking, Medical Support (For General Medical Purposes)

Product Code Classifications

CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00745129164720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00745129164720007451291647207451291647200745129164720

GMDN Terms

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 normally available [non-prescription] over-the-counter (OTC) for use in the home and/or for a hospitalized patient. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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 DIBrandModelCatalogPublished
07613378196171862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° Black3206013206012026-03-19
07613378196188862N-CUSTOM ECF2 AG Quadrinova UNI °° Black3206003206002026-03-19
07613378196577862N-CUSTOM ECF2 AG Quadrinova UNI Black3205613205612026-03-19
07613378196959862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° Caramel3205233205232026-03-19
07613378196966862N-CUSTOM ECF2 AG Quadrinova UNI °° Caramel3205223205222026-03-19
07613378197352862N-CUSTOM ECF2 AG Quadrinova UNI Caramel3204833204832026-03-19
07613378197734862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° Grey3204453204452026-03-19
07613378197741862N-CUSTOM ECF2 AG Quadrinova UNI °° Grey3204443204442026-03-19
07613378198137862N-CUSTOM ECF2 AG Quadrinova UNI Grey3204053204052026-03-19
07613378198519862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° Savanna3203673203672026-03-19
07613378198526862N-CUSTOM ECF2 AG Quadrinova UNI °° Savanna3203663203662026-03-19
07613378198915862N-CUSTOM ECF2 AG Quadrinova UNI Savanna3203273203272026-03-19
07613378199301862N-CUSTOM ECF2 AG Quadrinova UNI °° Skin3202883202882026-03-19
07613378199691862N-CUSTOM ECF2 AG Quadrinova UNI Skin3202493202492026-03-19
07613378277122862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Grey3554563554562026-03-19
07613378277139862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Caramel3554573554572026-03-19
07613378277146862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Skin3554583554582026-03-19
07613378277153862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Savanna3554593554592026-03-19
07613378277177862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Marine3554613554612026-03-19
07613378277184862N-CUSTOM ECF2 AG Micro knobbed band UNI Grey3554623554622026-03-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08300496072157SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072164SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072171SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072188SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072195SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072201SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072218SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072225SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072232SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072331SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072348SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072355SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072362SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072379SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072386SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072393SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072409SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072416SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072423SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072430SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072447SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072454SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072461SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072478SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072485SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072492SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072508SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072515SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072522SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072539SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20