SOLIDEA

Basic Information

• Brand Name: SOLIDEA
• Primary DI: 08300496042846
• Version / Model: 042846
• Catalog Number: 0432A8
• Company Name: CALZIFICIO PINELLI SRL
• Labeler DUNS: 431221795
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-21
• Public Version: 2
• Public Version Date: 2022-01-17
• Public Version Status: Update
• Public Device Record Key: 0bc427e4-cb37-4856-9772-4ab918eaf3d1

Device Description

ARM CARE CCL.1, SIZE M, NATUR, GRADUATED COMPRESSION 15/21 mmHg ARMBAND

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
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	880.5780	2

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	08300496042846	GS1