AccessGUDID - DEVICE: GRILLO POSTURAL SYSTEM (08054040400230)

GUDID

Device Identifier (DI) Information

Brand Name: GRILLO POSTURAL SYSTEM
Version or Model: GRILLO P.SYS-S 856 CUSC.PINK
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORMESA SRL

Primary DI Number: 08054040400230
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432070019 *Terms of Use

Device Description: Postural sitting unit intended for children with disabilities (Infantile Cerebral Palsy, degenerative pathologies with functional impairments, syndromic pathologies with impairments functional) easily adaptable thanks to its modularity. Suitable for users who have little or no control of the trunk and head and needing appropriate stabilization a pelvic level to be able to assume, in situations where residual functionality allows it, the more appropriate posture in different everyday contexts, both internally and externally.

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: 1ca2d59b-ebab-47ce-9bec-d9f36b9e887f
Public Version Date: June 30, 2025
Public Version Number: 1
DI Record Publish Date: June 20, 2025