SOLIDEA

Basic Information

• Brand Name: SOLIDEA
• Primary DI: 08300496020165
• Version / Model: 020165
• Catalog Number: 0169A0
• Company Name: CALZIFICIO PINELLI SRL
• Labeler DUNS: 431221795
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-29
• Public Version: 2
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: 78576bc1-c81e-4b45-ad01-7c28a2e39a76

Device Description

VENERE 100, SIZE S, SABBIA, GRADUATED COMPRESSION 15/18 mmHg SHEER TO THE WAIST TIGHTS

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
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	880.5780	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42811	Compression/pressure sock/stocking, reusable	A garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08300496020165	GS1