FDA.reportPublic FDA data

SOLIDEA

Primary DI
08300496023142
Brand
SOLIDEA
Company
CALZIFICIO PINELLI SRL
Model
023142
Catalog number
023470
Device description
SELENE 70 OPAQUE, SIZE XXL, NERO, GRADUATED COMPRESSION 12/15 mmHg OPAQUE TIGHTS
Published
2020-07-23
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
08300496023142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08300496023142083004960231428300496023142

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
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
08300496074489SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074496SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074502SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074519SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074526SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074533SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074540SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074557SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
08300496074564SOLIDEACALZIFICIO PINELLI SRLFQL2026-10-16
00674854000013SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000020SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000037SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000044SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000068SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000075SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000082SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000099SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000105SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000112SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000129SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000136SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000143SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000150SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000167SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000174SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000181SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000198SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000204SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000211SOFT SOCK ®Thuasne LLCFQL2018-12-31
00674854000228SOFT SOCK ®Thuasne LLCFQL2018-12-31