AccessGUDID - DEVICE: GRILLO ADAPTIVE SEATING (08055715708088)

GUDID

Device Identifier (DI) Information

Brand Name: GRILLO ADAPTIVE SEATING
Version or Model: GRILLO ADAPTIVE SEATING ROSA mis. mini con 835 poggiatesta imbottito, sagomato e
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORMESA SRL

Primary DI Number: 08055715708088
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432070019 *Terms of Use

Device Description: GRILLO ADAPTIVE SEATING is an adjustable configuration seating system intended for children and young people with disabilities who need special supports, supports and adjustments in carrying out daily, educational and recreational activities, easily adaptable thanks to its modularity. It allows the person with disabilities of varying complexity to be positioned in the most appropriate and functional posture for the different contexts of daily life. Indicated for users who have little or no control of the trunk and head and who need adequate stabilization at the pelvic level to be able to assume, in situations where residual functionality allows it, the most appropriate posture in the various contexts.

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
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: 31b4719d-98e5-40bb-9d11-2950069ba6bf
Public Version Date: February 10, 2025
Public Version Number: 1
DI Record Publish Date: January 31, 2025