AccessGUDID - DEVICE: TM "Rehabilitimed" OT-1V XL Comfort (04823097717394)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 04823097717394
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 color posture corrector. The back of the posture corrector is made of multilayer material (tripled cotton fabric (glued in a special way with polyurethane foam) with a mesh fabric), equipped with 2 modeled stiffening ribs, which, in combination with reclining straps, allow for gradual posture correction due to adjustable shoulder separation with simultaneous fixation of the lumbar spine.

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?
41042	Thoracic spine orthosis	A prefabricated (non-customized) orthopaedic corset designed to encompasses the thoracic spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine through compression of the abdomen. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IPT	Orthosis, Thoracic

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: Hip circumference below the waistline by 10 cm (cm): > 106
Device Size Text, specify: Clothing size compliance: 52-54

Device Record Status

Public Device Record Key: 4ad058b1-cfe9-4fd0-b0fa-e70c31c8d491
Public Version Date: May 13, 2025
Public Version Number: 1
DI Record Publish Date: May 05, 2025