FDA.reportPublic FDA data

SOLIDEA

Primary DI
08300496070474
Brand
SOLIDEA
Company
CALZIFICIO PINELLI SRL
Model
070474
Catalog number
0615B5
Device description
BE YOU TONIC PRO, SIZE S, RIBES, GRADUATED COMPRESSION 15/21 mmHg OPAQUE MICRO-MASSAGING LEGGINGS WITH A THREE-DIMENSIONAL CONSTRUCTION AND OPEN TOE FOR OUTDOOR USE
Published
2025-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
08300496070474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08300496070474083004960704748300496070474

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.

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
08300496033981SOLIDEA0339810318702026-05-15
08300496071099SOLIDEA0710990318702026-05-15
08300496073109SOLIDEA073109 0602B52026-05-15
08300496073116SOLIDEA073116 0602B52026-05-15
08300496073123SOLIDEA073123 0602B52026-05-15
08300496073130SOLIDEA073130 0602B52026-05-15
08300496073147SOLIDEA073147 0602B52026-05-15
08300496073154SOLIDEA0731540603B52026-05-15
08300496073161SOLIDEA0731610603B52026-05-15
08300496073178SOLIDEA0731780603B52026-05-15
08300496073185SOLIDEA0731850603B52026-05-15
08300496073192SOLIDEA073192 0602B52026-05-15
08300496073208SOLIDEA073208 0602B52026-05-15
08300496073215SOLIDEA073215 0602B52026-05-15
08300496073222SOLIDEA073222 0602B52026-05-15
08300496073239SOLIDEA073239 0602B52026-05-15
08300496073246SOLIDEA0732460613A52026-05-15
08300496073253SOLIDEA0732530613A52026-05-15
08300496073260SOLIDEA0732600613A52026-05-15
08300496073277SOLIDEA0732770613A52026-05-15

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