AccessGUDID - DEVICE: TM "Rehabilitimed" L-4M-2 XXXL Comfort (04823097719596)

GUDID

Device Identifier (DI) Information

Brand Name: TM "Rehabilitimed" L-4M-2 XXXL Comfort
Version or Model: L-4M-2 XXXL Comfort
Commercial Distribution Status: In Commercial Distribution
Catalog Number: L-4M-2 XXXL Comfort
Company Name: REABILITIMED TOV

Primary DI Number: 04823097719596
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 364875768 *Terms of Use

Device Description: The beige orthopedic device for the lumbar spine, 24 cm high, is made of elastic bandage fabric and multilayer material (special velor fabric tripled (glued in a special way with polyurethane foam) with cotton terry cloth), which, together with stiffening ribs (metal ribs) and additional ties, allows you to provide reliable support for the lumbar spine, taking the form of lumbar lordosis.

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?
66086	Multiple spinal region orthosis	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRI	Orthosis, Truncal/Orthosis, Limb

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: Hips 10 cm below the waistline (cm): 128-138
Device Size Text, specify: Corset length (cm): 143-147

Device Record Status

Public Device Record Key: fee70353-7bcf-490f-8a83-3977f6791d41
Public Version Date: May 13, 2025
Public Version Number: 1
DI Record Publish Date: May 05, 2025