FDA.reportPublic FDA data

SOLIDEA

Primary DI
08300496061854
Brand
SOLIDEA
Company
CALZIFICIO PINELLI SRL
Model
61854
Catalog number
0419A8
Device description
WONDER MODEL CCL.1 OPEN TOE, SIZE XXL, BLU SCURO, GRADUATED COMPRESSION 18/21 mmHg TIGHTS
Published
2019-06-04
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
08300496061854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08300496061854083004960618548300496061854

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
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
00850073571385American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571392American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571415American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571422American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571446American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571453American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571477American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
00850073571484American Hospital SupplyAmerican Hospital Supply LLCDWL2026-06-09
G4200211Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4200221Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201021Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201031Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201041Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201061Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4202011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4202021Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203001Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203021Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203031Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203041Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203051Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203061Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203071Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203081Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203091Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203311Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203321Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203331Compression StockingGottfried Medical, Inc.DWL2026-06-04