TM "Soloventex" 421-231 L

Basic Information

• Brand Name: TM "Soloventex" 421-231 L
• Primary DI: 04823097718797
• Version / Model: 421-231 L
• Catalog Number: 421-231 L
• Company Name: REABILITIMED TOV
• Labeler DUNS: 364875768
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-23
• Public Version: 1
• Public Version Date: 2025-05-01
• Public Version Status: New
• Public Device Record Key: aba572fc-139a-4de3-a5c7-8407c69e4273

Device Description

These are men's stockings with a closed toe, 2nd compression class 23-32 mm. Hg., black color, dense structure, made of elastane and polyamide. The compression effect of the knitwear causes the following therapeutic effects: narrows the lumen of the veins, increases the rate of venous blood outflow, prevents its stagnation, normalizes the activity of the muscular-venous pump; prevents the formation of blood clots; protects the legs from swelling, fatigue and pain.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Has Expiration Date: Yes
• 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
30878	Compression/pressure sock/stocking, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04823097718797	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Pressure: 23-32 mm. Hg.
Device Size Text, specify			Circumference (cm): cB 25,5-27,5; cC 37,0-43,0; cD 37,0-42,0; cG 55,0-62,0
Device Size Text, specify			Lenght (cm): lG 83,1-92,0