FDA.report

TM "Soloventex" 421-242 L

Primary DI
04823097718643
Brand
TM "Soloventex" 421-242 L
Company
REABILITIMED TOV
Model
421-242 L
Catalog number
421-242 L
Device description
These are men's stockings with a closed toe, 2nd compression class 23-32 mm. Hg., beige 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.
Published
2025-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FQLStocking, Medical Support (For General Medical Purposes)

Product Code Classifications

CodeDeviceSpecialtyClass
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04823097718643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04823097718643048230977186434823097718643

GMDN Terms

TermDefinition
Compression/pressure sock/stocking, single-useA 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
835 5030395Krut.Lora@gmail.com

Regulatory Flags

DUNS number
364875768
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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04823097718223TM "Soloventex" 621-142 S621-142 S621-142 S2025-06-26
04823097718230TM "Soloventex" 621-142 M621-142 M621-142 M2025-06-26
04823097718247TM "Soloventex" 621-142 L621-142 L621-142 L2025-06-26
04823097718254TM "Soloventex" 621-142 XL621-142 XL621-142 XL2025-06-26
04823097718261TM "Soloventex" 621-142 XXL621-142 XXL621-142 XXL2025-06-26
04823097718278TM "Soloventex" 621-132 S621-132 S621-132 S2025-06-26
04823097718285TM "Soloventex" 621-132 M621-132 M621-132 M2025-06-26
04823097718292TM "Soloventex" 621-132 L621-132 L621-132 L2025-06-26
04823097718308TM "Soloventex" 621-132 XL621-132 XL621-132 XL2025-06-26
04823097718315TM "Soloventex" 621-132 XXL621-132 XXL621-132 XXL2025-06-26
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04823097721674TM "Rehabilitimed" BR-2 L ComfortBR-2 L ComfortBR-2 L Comfort2025-06-19
04823097721681TM "Rehabilitimed" BR-2 XL ComfortBR-2 XL ComfortBR-2 XL Comfort2025-06-19
04823097721698TM "Rehabilitimed" BR-2 XXL ComfortBR-2 XXL ComfortBR-2 XXL Comfort2025-06-19
04823097723678TM "Rehabilitimed" BR-1 S ComfortBR-1 S ComfortBR-1 S Comfort2025-06-19
04823097723685TM "Rehabilitimed" BR-1 M ComfortBR-1 M ComfortBR-1 M Comfort2025-06-19
04823097723692TM "Rehabilitimed" BR-1 L ComfortBR-1 L ComfortBR-1 L Comfort2025-06-19
04823097723708TM "Rehabilitimed" BR-1 XL ComfortBR-1 XL ComfortBR-1 XL Comfort2025-06-19
04823097723715TM "Rehabilitimed" BR-1 XXL ComfortBR-1 XXL ComfortBR-1 XXL Comfort2025-06-19

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