FDA.report

TM "Rehabilitimed" BR-2 XXL

Primary DI
04823097706923
Brand
TM "Rehabilitimed" BR-2 XXL
Company
REABILITIMED TOV
Model
BR-2 XXL
Catalog number
BR-2 XXL
Device description
It is a white chest bandage, with a dense structure. The part of the bandage that fits the back is made of elastic fabric, and the front and side parts are made of a multilayer material (special velour fabric tripled (glued in a special way with polyurethane foam) with cotton terry cloth, and is equipped with 2 plastic stiffening ribs.
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
IPXOrthosis, Rib Fracture, Soft

Product Code Classifications

CodeDeviceSpecialtyClass
IPXOrthosis, Rib Fracture, SoftPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04823097706923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04823097706923048230977069234823097706923

GMDN Terms

TermDefinition
Lumbar spine orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. 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
00190446660576PROCAREDJO, LLCIPX2025-07-23
04823097721650TM "Rehabilitimed" BR-2 S ComfortREABILITIMED TOVIPX2025-06-19
04823097721667TM "Rehabilitimed" BR-2 M ComfortREABILITIMED TOVIPX2025-06-19
04823097721674TM "Rehabilitimed" BR-2 L ComfortREABILITIMED TOVIPX2025-06-19
04823097721681TM "Rehabilitimed" BR-2 XL ComfortREABILITIMED TOVIPX2025-06-19
04823097721698TM "Rehabilitimed" BR-2 XXL ComfortREABILITIMED TOVIPX2025-06-19
04823097723678TM "Rehabilitimed" BR-1 S ComfortREABILITIMED TOVIPX2025-06-19
04823097723685TM "Rehabilitimed" BR-1 M ComfortREABILITIMED TOVIPX2025-06-19
04823097723692TM "Rehabilitimed" BR-1 L ComfortREABILITIMED TOVIPX2025-06-19
04823097723708TM "Rehabilitimed" BR-1 XL ComfortREABILITIMED TOVIPX2025-06-19
04823097723715TM "Rehabilitimed" BR-1 XXL ComfortREABILITIMED TOVIPX2025-06-19
04823097706886TM "Rehabilitimed" BR-2 SREABILITIMED TOVIPX2025-05-04
04823097706893TM "Rehabilitimed" BR-2 MREABILITIMED TOVIPX2025-05-04
04823097706909TM "Rehabilitimed" BR-2 LREABILITIMED TOVIPX2025-05-04
04823097706916TM "Rehabilitimed" BR-2 XLREABILITIMED TOVIPX2025-05-04
04823097706930TM "Rehabilitimed" BR-2 XXXLREABILITIMED TOVIPX2025-05-04
04823097706947TM "Rehabilitimed" BR-2 SREABILITIMED TOVIPX2025-05-04
04823097706954TM "Rehabilitimed" BR-2 MREABILITIMED TOVIPX2025-05-04
04823097706961TM "Rehabilitimed" BR-2 LREABILITIMED TOVIPX2025-05-04
04823097706978TM "Rehabilitimed" BR-2 XLREABILITIMED TOVIPX2025-05-04
04823097706985TM "Rehabilitimed" BR-2 XXLREABILITIMED TOVIPX2025-05-04
04823097706992TM "Rehabilitimed" BR-2 XXXLREABILITIMED TOVIPX2025-05-04
10609271950105MECRON Belt B: 22 cm, U: 66-86 cmDARCO INTERNATIONAL, INC.IPX2023-02-14
10609271950112MECRON Belt B: 22 cm, U: 84-110 cmDARCO INTERNATIONAL, INC.IPX2023-02-14
10609271950129MECRON Belt B: 22 cm, U: 105-127 cmDARCO INTERNATIONAL, INC.IPX2023-02-14
10609271950136MECRON Belt B: 22 cm, U: 130-157 cmDARCO INTERNATIONAL, INC.IPX2023-02-14
10609271950143MECRON Belt B: 29 cm, U: 66-86 cmDARCO INTERNATIONAL, INC.IPX2023-02-14
10609271950150MECRON Belt B: 29 cm, U: 84-110 cmDARCO INTERNATIONAL, INC.IPX2023-02-14
10609271950167MECRON Belt B: 29 cm, U: 105-127 cmDARCO INTERNATIONAL, INC.IPX2023-02-14
10609271950174MECRON Belt B: 29 cm, U: 130-157 cmDARCO INTERNATIONAL, INC.IPX2023-02-14