FDA.report

TM "Rehabilitimed" S-4 XXL Comfort

Primary DI
04823097716670
Brand
TM "Rehabilitimed" S-4 XXL Comfort
Company
REABILITIMED TOV
Model
S-4 XXL Comfort
Catalog number
S-4 XXL Comfort
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 fabric tripled (glued in a special way with polyurethane foam) with cotton terry cloth), with 2 plastic stiffening ribs. The height of the corset is 30 cm.
Published
2025-05-04
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
KTDOrthosis, Abdominal

Product Code Classifications

CodeDeviceSpecialtyClass
KTDOrthosis, AbdominalPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04823097716670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04823097716670048230977166704823097716670

GMDN Terms

TermDefinition
Abdominal binder, reusableA 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.

Device Sizes

TypeValueUnit
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

Primary DIBrandModelCatalogPublished
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
04823097721650TM "Rehabilitimed" BR-2 S ComfortBR-2 S ComfortBR-2 S Comfort2025-06-19
04823097721667TM "Rehabilitimed" BR-2 M ComfortBR-2 M ComfortBR-2 M Comfort2025-06-19
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04823097716618TM "Rehabilitimed" S-3M XXXL ComfortREABILITIMED TOVKTD2025-05-04
04823097716625TM "Rehabilitimed" S-3 XXXL ComfortREABILITIMED TOVKTD2025-05-04
04823097716632TM "Rehabilitimed" S-3M XXL ComfortREABILITIMED TOVKTD2025-05-04
04823097716649TM "Rehabilitimed" S-4M L ComfortREABILITIMED TOVKTD2025-05-04
04823097716656TM "Rehabilitimed" S-3 L ComfortREABILITIMED TOVKTD2025-05-04
04823097716663TM "Rehabilitimed" S-3 XL ComfortREABILITIMED TOVKTD2025-05-04
04823097716687TM "Rehabilitimed" S-4 XL ComfortREABILITIMED TOVKTD2025-05-04
04823097716694TM "Rehabilitimed" S-4 M ComfortREABILITIMED TOVKTD2025-05-04
04823097716700TM "Rehabilitimed" S-4 L ComfortREABILITIMED TOVKTD2025-05-04
04823097716717TM "Rehabilitimed" S-4 XXXL ComfortREABILITIMED TOVKTD2025-05-04
04823097716724TM "Rehabilitimed" S-3 M ComfortREABILITIMED TOVKTD2025-05-04
04823097716731TM "Rehabilitimed" S-4M M ComfortREABILITIMED TOVKTD2025-05-04
04823097716748TM "Rehabilitimed" S-3M L ComfortREABILITIMED TOVKTD2025-05-04
04823097716755TM "Rehabilitimed" S-4M XXXL ComfortREABILITIMED TOVKTD2025-05-04
04823097716762TM "Rehabilitimed" S-3M XL ComfortREABILITIMED TOVKTD2025-05-04
04823097716779TM "Rehabilitimed" S-4M XXL ComfortREABILITIMED TOVKTD2025-05-04
04823097716786TM "Rehabilitimed" S-3M M ComfortREABILITIMED TOVKTD2025-05-04
04823097716793TM "Rehabilitimed" S-4M XL ComfortREABILITIMED TOVKTD2025-05-04
04823097716809TM "Rehabilitimed" S-3 XXL ComfortREABILITIMED TOVKTD2025-05-04
04823097716861TM "Rehabilitimed" S-3 S ComfortREABILITIMED TOVKTD2025-05-04
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