AccessGUDID - DEVICE: TM "Soloventex" 550-241 XL Right (04823097718056)

GUDID

Device Identifier (DI) Information

Brand Name: TM "Soloventex" 550-241 XL Right
Version or Model: 550-241 XL Right
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 550-241 XL Right
Company Name: REABILITIMED TOV

Primary DI Number: 04823097718056
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 364875768 *Terms of Use

Device Description: It is a monostocking with an adjustable belt with an open toe, 2nd compression class 23-32 mm. Hg., black color, tight 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 edema, fatigue and pain.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQL	Stocking, Medical Support (For General Medical Purposes)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Pressure: 23-32 mm. Hg.
Device Size Text, specify: Circumference (cm): cB 28,0-31,0; cC 40,0-47,0; cD 40,0-45,0; cG 60,0-67,0; cT 95-125
Device Size Text, specify: Lenght (cm): lG 74,1-83,0

Device Record Status

Public Device Record Key: 926b19a9-a43d-4fa8-ae9c-7055c971b839
Public Version Date: May 01, 2025
Public Version Number: 1
DI Record Publish Date: April 23, 2025