FDA.reportPublic FDA data

SOLIDEA

Primary DI
08300496044628
Brand
SOLIDEA
Company
CALZIFICIO PINELLI SRL
Model
44628
Catalog number
0423A8
Device description
MARILYN CCL.1 OPEN TOE, SIZE S, MOKA, GRADUATED COMPRESSION 18/21 mmHg STAY UP STOCKINGS
Published
2019-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08300496044628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08300496044628083004960446288300496044628

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
431221795
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08300496073765SOLIDEA0737650619A52026-10-16
08300496073772SOLIDEA0737720619A52026-10-16
08300496073789SOLIDEA0737890619A52026-10-16
08300496073796SOLIDEA0737960619A52026-10-16
08300496073802SOLIDEA0738020619A52026-10-16
08300496073819SOLIDEA0738190619A52026-10-16
08300496073826SOLIDEA0738260620A52026-10-16
08300496073833SOLIDEA0738330620A52026-10-16
08300496073840SOLIDEA0738400620A52026-10-16
08300496073857SOLIDEA0738570620A52026-10-16
08300496073864SOLIDEA0738650620A52026-10-16
08300496073871SOLIDEA0738710620A52026-10-16
08300496073888SOLIDEA0738880656B82026-10-16
08300496073895SOLIDEA0738950656B82026-10-16
08300496073901SOLIDEA0739010656B82026-10-16
08300496073918SOLIDEA0739180656B82026-10-16
08300496073925SOLIDEA0739250656B82026-10-16
08300496073932SOLIDEA0739320656B82026-10-16
08300496073949SOLIDEA0739490656B82026-10-16
08300496073956SOLIDEA0739560656B82026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08300496073888SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073895SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073901SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073918SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073925SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073932SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073949SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073956SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073963SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073970SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073987SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496073994SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074007SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074014SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074021SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074038SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074045SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074052SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074069SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074076SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074083SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074090SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074106SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074113SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074120SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074137SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074144SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074151SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074168SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16
08300496074175SOLIDEACALZIFICIO PINELLI SRLDWL2026-10-16