AccessGUDID - DEVICE: TM "Rehabilitimed" BR-1 S Comfort (04823097723678)

GUDID

Device Identifier (DI) Information

Brand Name: TM "Rehabilitimed" BR-1 S Comfort
Version or Model: BR-1 S Comfort
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BR-1 S Comfort
Company Name: REABILITIMED TOV

Primary DI Number: 04823097723678
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 364875768 *Terms of Use

Device Description: It is a graphite colored chest bandage. The part of the bandage that fits to the back is made of elastic fabric, and the front-side parts are made of rich ball material (a special velor tri-laminated fabric (glued in a special way with polyurethane foam) with a rich terry cloth, complete with 2 plastic ribs.

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?
33031	Lumbar spine orthosis	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IPX	Orthosis, Rib Fracture, Soft

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: Thorax circumference (cm): < 80
Device Size Text, specify: Thorax circumference (inch): up to 31,5

Device Record Status

Public Device Record Key: f4868e66-d914-4222-b3b3-ec3a8fe0c18a
Public Version Date: June 27, 2025
Public Version Number: 1
DI Record Publish Date: June 19, 2025