FDA.reportPublic FDA data

SOLIDEA

Primary DI
08300496030492
Brand
SOLIDEA
Company
CALZIFICIO PINELLI SRL
Model
030492
Catalog number
0352A4
Device description
WONDER MODEL MAMAN 140 SHEER, SIZE S, GLACE, GRADUATED COMPRESSION 18/21 mmHg SHEER SHAPEWEAR TIGHTS FOR EXPECTANT MOTHERS WITH A POUCH AND A SUPPORTING BAND SUITABLE FOR THE GROWING BELLY
Published
2020-06-25
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
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
08300496030492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08300496030492083004960304928300496030492

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
07613378196126862P-CUSTOM ECF2 AT1L SoftTop FEM °° BlackSIGVARIS INCFQL2026-07-22
07613378196522862P-CUSTOM ECF2 AT SoftTop MEN BlackSIGVARIS INCFQL2026-07-22
07613378196911862P-CUSTOM ECF2 AT SoftTop MEN °° CaramelSIGVARIS INCFQL2026-07-22
07613378197307862P-CUSTOM ECF2 AT SoftTop MEN CaramelSIGVARIS INCFQL2026-07-22
07613378197697862P-CUSTOM ECF2 AT SoftTop MEN °° GreySIGVARIS INCFQL2026-07-22
07613378198083862P-CUSTOM ECF2 AT SoftTop MEN GreySIGVARIS INCFQL2026-07-22
07613378198472862P-CUSTOM ECF2 AT SoftTop MEN °° SavannaSIGVARIS INCFQL2026-07-22
07613378198861862P-CUSTOM ECF2 AT SoftTop MEN SavannaSIGVARIS INCFQL2026-07-22
07613378199257862P-CUSTOM ECF2 AT SoftTop MEN °° SkinSIGVARIS INCFQL2026-07-22
07613378199646862P-CUSTOM ECF2 AT SoftTop MEN SkinSIGVARIS INCFQL2026-07-22
07613378277542862P-CUSTOM ECF2 AT SoftTop MEN marineSIGVARIS INCFQL2026-07-22
07613378277931862P-CUSTOM ECF2 AT SoftTop MEN °° marineSIGVARIS INCFQL2026-07-22
07613378196133862P-CUSTOM ECF2 AT SoftTop MEN °° BlackSIGVARIS INCFQL2026-07-20
07613378196539862P-CUSTOM ECF2 AT SoftTop FEM BlackSIGVARIS INCFQL2026-07-20
07613378196928862P-CUSTOM ECF2 AT SoftTop FEM °° CaramelSIGVARIS INCFQL2026-07-20
07613378197314862P-CUSTOM ECF2 AT SoftTop FEM CaramelSIGVARIS INCFQL2026-07-20
07613378197703862P-CUSTOM ECF2 AT SoftTop FEM °° GreySIGVARIS INCFQL2026-07-20
07613378198090862P-CUSTOM ECF2 AT SoftTop FEM GreySIGVARIS INCFQL2026-07-20
07613378198489862P-CUSTOM ECF2 AT SoftTop FEM °° SavannaSIGVARIS INCFQL2026-07-20
07613378198878862P-CUSTOM ECF2 AT SoftTop FEM SavannaSIGVARIS INCFQL2026-07-20
07613378199264862P-CUSTOM ECF2 AT SoftTop FEM °° SkinSIGVARIS INCFQL2026-07-20
07613378199653862P-CUSTOM ECF2 AT SoftTop FEM SkinSIGVARIS INCFQL2026-07-20
07613378277535862P-CUSTOM ECF2 AT SoftTop FEM marineSIGVARIS INCFQL2026-07-20
07613378277924862P-CUSTOM ECF2 AT SoftTop FEM °° marineSIGVARIS INCFQL2026-07-20
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