SOLIDEA

Basic Information

• Brand Name: SOLIDEA
• Primary DI: 08300496069034
• Version / Model: 069034
• Catalog Number: 0619A5
• Company Name: CALZIFICIO PINELLI SRL
• Labeler DUNS: 431221795
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-31
• Public Version: 1
• Public Version Date: 2025-11-10
• Public Version Status: New
• Public Device Record Key: c44b954d-525c-48a6-ad5a-4238b20fd2e8

Device Description

T-SKIN, SIZE XS, NERO, MICRO-MASSAGING VEST WITH A THREE-DIMENSIONAL CONSTRUCTION

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDR	Binder, Medical, Therapeutic	General Hospital	880.5160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64438	Compression/pressure tubular garment	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08300496069034	GS1