FDA.reportPublic FDA data

SOLIDEA

Primary DI
08300496036531
Brand
SOLIDEA
Company
CALZIFICIO PINELLI SRL
Model
036531
Catalog number
0390B8
Device description
SUPPORT ELBOW, SIZE M, CAMEL, GRADUATED COMPRESSION 18/21 mmHg ELBOW SUPPORT
Published
2025-12-08
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
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
08300496036531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08300496036531083004960365318300496036531

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.

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
10192253015980T.E.D.Cardinal Health 200, LLCDWL2026-05-20
08300496042921SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496042938SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496042945SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496042952SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496042969SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496042976SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496053767SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496053774SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496053781SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496062585SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496063667SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496067535SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
10192253015881T.E.D.Cardinal Health 200, LLCDWL2024-09-24
10192253015904T.E.D.Cardinal Health 200, LLCDWL2024-09-24
10192253015911T.E.D.Cardinal Health 200, LLCDWL2024-09-24
10192253015928T.E.D.Cardinal Health 200, LLCDWL2024-09-24
10192253015591T.E.D.Cardinal Health 200, LLCDWL2024-06-10
10612479266954McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479266978McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479266992McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267012McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267036McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267050McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267074McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267098McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267111McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267135McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267159McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267173McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16