AccessGUDID - DEVICE: JUDITTA (08055715701607)

GUDID

Device Identifier (DI) Information

Brand Name: JUDITTA
Version or Model: JUDITTA-50 B30 DARK GREY, WHITE FRAME
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORMESA SRL

Primary DI Number: 08055715701607
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432070019 *Terms of Use

Device Description: Tilting seating system intended for users with significant systemic, neurological, orthopedic impairment; patients with reduced or no degree of mobility, poor control of the trunk and head, Patients who, due to the permanence in a sitting or lying position, have an average risk index of onset of pressure ulcers (according to the Norton or Braden scale), for which the transpiration of the surfaces (back and seat) is decisive for the maintenance of dry skin, to avoid skin maceration and topical infections. Patients with severe structured spinal deformities, in particular major kyphoscoliosis. Patients with difficulty in controlling and tending to lose the proper position of the pelvis, in order to slide forward.

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":	No
For Single-Use:	No
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?
41630	Attendant-only-propelled wheelchair, non-bariatric	A non-powered wheeled mobility device with a seat designed to enable a healthcare provider/carer to transport a non-bariatric person without the full capacity to walk, typically over short distances and over smooth ground. Often referred to as a transport wheelchair, it is typically designed with four small wheels and includes rear-fitted handles for attendant control of the chair; it does not provide the occupant a mechanism for self-propulsion (it is not a push-rim wheelchair). It provides no function outside of wheeled mobilization.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INM	Chair, With Casters

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
No Device Sizes

Device Record Status

Public Device Record Key: e2e67582-0684-45c2-a88a-ce39872db511
Public Version Date: February 10, 2025
Public Version Number: 1
DI Record Publish Date: January 31, 2025