FDA.reportPublic FDA data

SOLIDEA

Primary DI
08300496073789
Brand
SOLIDEA
Company
CALZIFICIO PINELLI SRL
Model
073789
Catalog number
0619A5
Device description
T-SKIN, SIZE M, CHAMPAGNE, MICRO-MASSAGING VEST WITH A THREE-DIMENSIONAL CONSTRUCTION
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
MDRBinder, Medical, Therapeutic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDRBinder, Medical, TherapeuticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08300496073789PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08300496073789083004960737898300496073789

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
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
08300496073963SOLIDEA0739630656B82026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08300496073765SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073772SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073796SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073802SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073819SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073826SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073833SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073840SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073857SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073864SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073871SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
00745129335069Envelo Arm Wrap Small Short BeigeSIGVARIS INCMDR2026-07-22
00745129335076Envelo Arm Wrap Small Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335083Envelo Arm Wrap Small Long BeigeSIGVARIS INCMDR2026-07-22
00745129335090Envelo Arm Wrap Max Small Short BeigeSIGVARIS INCMDR2026-07-22
00745129335106Envelo Arm Wrap Max Small Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335113Envelo Arm Wrap Max Small Long BeigeSIGVARIS INCMDR2026-07-22
00745129335120Envelo Arm Wrap Medium Short BeigeSIGVARIS INCMDR2026-07-22
00745129335137Envelo Arm Wrap Medium Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335144Envelo Arm Wrap Medium Long BeigeSIGVARIS INCMDR2026-07-22
00745129335151Envelo Arm Wrap Max Medium Short BeigeSIGVARIS INCMDR2026-07-22
00745129335168Envelo Arm Wrap Max Medium Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335175Envelo Arm Wrap Max Medium Long BeigeSIGVARIS INCMDR2026-07-22
00745129335182Envelo Arm Wrap Large Short BeigeSIGVARIS INCMDR2026-07-22
00745129334918Envelo Arm Wrap Max Large Short BlackSIGVARIS INCMDR2026-07-20
00745129334925Envelo Arm Wrap Max Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129334932Envelo Arm Wrap Max Large Long BlackSIGVARIS INCMDR2026-07-20
00745129334949Envelo Arm Wrap X-Large Short BlackSIGVARIS INCMDR2026-07-20
00745129334956Envelo Arm Wrap X-Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129334963Envelo Arm Wrap X-Large Long BlackSIGVARIS INCMDR2026-07-20