AccessGUDID - DEVICE: GRILLO CHAIR (08055715708323)

GUDID

Device Identifier (DI) Information

Brand Name: GRILLO CHAIR
Version or Model: GRILLO CHAIR ROSA mis.SMALL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORMESA SRL

Primary DI Number: 08055715708323
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432070019 *Terms of Use

Device Description: Ergonomic and adjustable chair suitable for children with disabilities who need support during recreational, educational and daily life activities. It is an ergonomically designed seat designed to ensure maximum comfort for the child who, by improving their sitting posture, is encouraged to develop motor skills and hand-eye coordination, attention and therefore social inclusion.

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?
58827	Assistive ergonomic chair, manually-adjusted	A non-electrical device, that may include pneumatically-assisted features, intended to support and position a patient (disabled and/or discomforted) in a sitting posture while performing activities of daily living, including work-related activities. It is designed with manually-operated ergonomic adjustments (e.g., height and position adjustments) to provide improved personal body posture and/or to help prevent/reduce physical problems associated with poor mobility or sedentary lifestyle. It is not a wheelchair.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INN	Chair, Adjustable, Mechanical

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: 7026aaac-371c-431e-a8cd-9f6e62b13702
Public Version Date: February 10, 2025
Public Version Number: 1
DI Record Publish Date: January 31, 2025