FDA.reportPublic FDA data

SOLIDEA

Primary DI
08300496074472
Brand
SOLIDEA
Company
CALZIFICIO PINELLI SRL
Model
074472
Catalog number
0659B8
Device description
OPERA BAMBOO THERAP.CCL2 PLUS LINE OPEN TOE, SIZE XXL, BLU NAVY, GRADUATED COMPRESSION 23/32 mmHg KNEE-HIGH MADE OF PRECIOUS BAMBOO YARN
Published
2026-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
08300496074472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08300496074472083004960744728300496074472

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure tubular garmentA device in the form of a tube intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema; it is neither a strip/roll binder, glove, sock/stocking, nor tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex); it does not include antimicrobial features. This is a reusable device.

Regulatory Flags#

DUNS number
431221795
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
false
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 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
04026358026697VenoTrain softBauerfeind AGDWL2016-10-07
04026358026703VenoTrain softBauerfeind AGDWL2016-10-07
04026358026710VenoTrain softBauerfeind AGDWL2016-10-07
04026358026727VenoTrain softBauerfeind AGDWL2016-10-07
04026358026741VenoTrain softBauerfeind AGDWL2016-10-07
04026358026857VenoTrain softBauerfeind AGDWL2016-10-07
04026358026871VenoTrain softBauerfeind AGDWL2016-10-07
04026358026888VenoTrain softBauerfeind AGDWL2016-10-07
04026358027298VenoTrain softBauerfeind AGDWL2016-10-07
04026358027304VenoTrain softBauerfeind AGDWL2016-10-07
04026358027359VenoTrain softBauerfeind AGDWL2016-10-07
04026358027366VenoTrain softBauerfeind AGDWL2016-10-07
04026358027434VenoTrain softBauerfeind AGDWL2016-10-07
04026358027441VenoTrain softBauerfeind AGDWL2016-10-07
04026358027458VenoTrain softBauerfeind AGDWL2016-10-07
04026358027465VenoTrain softBauerfeind AGDWL2016-10-07
04026358027595VenoTrain softBauerfeind AGDWL2016-10-07
04026358027762VenoTrain softBauerfeind AGDWL2016-10-07
04026358027830VenoTrain softBauerfeind AGDWL2016-10-07
04026358027854VenoTrain softBauerfeind AGDWL2016-10-07
04026358026598VenoTrain softBauerfeind AGDWL2016-10-07
04026358026666VenoTrain softBauerfeind AGDWL2016-10-07
04026358026680VenoTrain softBauerfeind AGDWL2016-10-07
04026358026734VenoTrain softBauerfeind AGDWL2016-10-07
04026358026840VenoTrain softBauerfeind AGDWL2016-10-07
04026358027274VenoTrain softBauerfeind AGDWL2016-10-07
04026358027281VenoTrain softBauerfeind AGDWL2016-10-07
04026358027373VenoTrain softBauerfeind AGDWL2016-10-07
04026358027380VenoTrain softBauerfeind AGDWL2016-10-07
04026358027519VenoTrain softBauerfeind AGDWL2016-10-07