FDA.reportPublic FDA data

"TM ""Rehabilitimed"" L-4M-3 S Comfort"

Primary DI
04823097721872
Brand
"TM ""Rehabilitimed"" L-4M-3 S Comfort"
Company
REABILITIMED TOV
Model
L-4M-3 S Comfort
Catalog number
L-4M-3 S Comfort
Device description
Graphite-colored orthosis for the lumbar and sacral spine, used to stabilize the lumbosacral spine (Th10-S1). Equipped with 4 duralumin modeled stiffening ribs and a removable lordosis cushion. Made of durable elastic bandage fabric made of polyamide and elastane and multilayer material with a cotton layer to the body and polyamide on the outside.
Published
2025-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MRIOrthosis, Truncal/Orthosis, Limb

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRIOrthosis, Truncal/Orthosis, LimbPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04823097721872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04823097721872048230977218724823097721872

GMDN Terms#

Term, Definition table
TermDefinition
Multiple spinal region orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass two or more regions of the spine (e.g., sacroiliac, lumbosacral, thoracolumbosacral) to support or immobilize deformities, fractures, sprains, or strains of the spine, and may additionally provide support for the abdomen. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
835 5030395Krut.Lora@gmail.com
+380965139983shenyalipinskiy@gmail.com
+380937042825reabilitimed@ukr.net

Regulatory Flags#

DUNS number
364875768
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04823097718223"TM ""Soloventex"" 621-142 S"621-142 S621-142 S2025-06-26
04823097718230"TM ""Soloventex"" 621-142 M"621-142 M621-142 M2025-06-26
04823097718247"TM ""Soloventex"" 621-142 L"621-142 L621-142 L2025-06-26
04823097718254"TM ""Soloventex"" 621-142 XL"621-142 XL621-142 XL2025-06-26
04823097718261"TM ""Soloventex"" 621-142 XXL"621-142 XXL621-142 XXL2025-06-26
04823097718278"TM ""Soloventex"" 621-132 S"621-132 S621-132 S2025-06-26
04823097718285"TM ""Soloventex"" 621-132 M"621-132 M621-132 M2025-06-26
04823097718292"TM ""Soloventex"" 621-132 L"621-132 L621-132 L2025-06-26
04823097718308"TM ""Soloventex"" 621-132 XL"621-132 XL621-132 XL2025-06-26
04823097718315"TM ""Soloventex"" 621-132 XXL"621-132 XXL621-132 XXL2025-06-26
04823097721650"TM ""Rehabilitimed"" BR-2 S Comfort"BR-2 S ComfortBR-2 S Comfort2025-06-19
04823097721667"TM ""Rehabilitimed"" BR-2 M Comfort"BR-2 M ComfortBR-2 M Comfort2025-06-19
04823097721674"TM ""Rehabilitimed"" BR-2 L Comfort"BR-2 L ComfortBR-2 L Comfort2025-06-19
04823097721681"TM ""Rehabilitimed"" BR-2 XL Comfort"BR-2 XL ComfortBR-2 XL Comfort2025-06-19
04823097721698"TM ""Rehabilitimed"" BR-2 XXL Comfort"BR-2 XXL ComfortBR-2 XXL Comfort2025-06-19
04823097723678"TM ""Rehabilitimed"" BR-1 S Comfort"BR-1 S ComfortBR-1 S Comfort2025-06-19
04823097723685"TM ""Rehabilitimed"" BR-1 M Comfort"BR-1 M ComfortBR-1 M Comfort2025-06-19
04823097723692"TM ""Rehabilitimed"" BR-1 L Comfort"BR-1 L ComfortBR-1 L Comfort2025-06-19
04823097723708"TM ""Rehabilitimed"" BR-1 XL Comfort"BR-1 XL ComfortBR-1 XL Comfort2025-06-19
04823097723715"TM ""Rehabilitimed"" BR-1 XXL Comfort"BR-1 XXL ComfortBR-1 XXL Comfort2025-06-19

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