FDA.report

SOLIDEA

Primary DI
08300496036616
Brand
SOLIDEA
Company
CALZIFICIO PINELLI SRL
Model
036616
Catalog number
0389B8
Device description
SUPPORT KNEE, SIZE XL, BIANCO, GRADUATED COMPRESSION 23/32 mmHg KNEE SUPPORT
Published
2025-12-08
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

Related Records

Product Codes

CodeName
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Product Code Classifications

CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08300496036616PrimaryGS10

GMDN Terms

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

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 DIBrandModelCatalogPublished
08300496072157SOLIDEA072157 0644B52026-03-20
08300496072164SOLIDEA072164 0644B52026-03-20
08300496072171SOLIDEA072171 0644B52026-03-20
08300496072188SOLIDEA072188 0644B52026-03-20
08300496072195SOLIDEA072195 0644B52026-03-20
08300496072201SOLIDEA072201 0645B52026-03-20
08300496072218SOLIDEA072218 0645B52026-03-20
08300496072225SOLIDEA072225 0645B52026-03-20
08300496072232SOLIDEA072232 0645B52026-03-20
08300496072331SOLIDEA072331 0644B52026-03-20
08300496072348SOLIDEA072348 0644B52026-03-20
08300496072355SOLIDEA072355 0644B52026-03-20
08300496072362SOLIDEA072362 0644B52026-03-20
08300496072379SOLIDEA072379 0644B52026-03-20
08300496072386SOLIDEA072386 0644B52026-03-20
08300496072393SOLIDEA072393 0644B52026-03-20
08300496072409SOLIDEA072409 0644B52026-03-20
08300496072416SOLIDEA072416 0644B52026-03-20
08300496072423SOLIDEA072423 0644B52026-03-20
08300496072430SOLIDEA072430 0644B52026-03-20

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Primary DIBrandCompanyProduct codePublished
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