TM "Rehabilitimed" S-4M M Comfort

Basic Information

• Brand Name: TM "Rehabilitimed" S-4M M Comfort
• Primary DI: 04823097716731
• Version / Model: S-4M M Comfort
• Catalog Number: S-4M M Comfort
• Company Name: REABILITIMED TOV
• Labeler DUNS: 364875768
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-04
• Public Version: 1
• Public Version Date: 2025-05-12
• Public Version Status: New
• Public Device Record Key: 131806f9-7413-49c8-928c-cabf456c7a48

Device Description

It is a surgical bandage for the abdominal wall, beige in color. The part of the bandage adjacent to the back and the right front-side parts that perform fixation are made of elastic bandage fabric, and the left front-side part located on the abdomen is made of multilayer material (special velor triple-layered fabric (glued in a special way with polyurethane foam) with cotton terry cloth), with 2 plastic stiffening ribs. The versatility of the bandage lies in the presence of two front-side elastic ties instead of the front-side part made of solid elastic cloth and is specially designed for patients with a large difference in the volume of the waist and hips. The height of the corset is 30 cm.

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
KTD	Orthosis, Abdominal	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47217	Abdominal binder, reusable	A strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04823097716731	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			Hips 10 cm below the waistline (cm): 87-95