AccessGUDID - DEVICE: GRILLO (08055715700181)

GUDID

Device Identifier (DI) Information

Brand Name: GRILLO
Version or Model: GRILLO MEDIUM POSTERIORE P
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORMESA SRL

Primary DI Number: 08055715700181
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432070019 *Terms of Use

Device Description: Postural walker (gait trainer) indicated for subjects who need support / support for maintaining the upright position and setting the gait, where the residual of functional capacity allows it, and for whom the gait trainer can be a stimulus to improve one's ability to discover the space around oneself and the environment, to perceive depth, to stimulate proactivity, to improve social interaction. The great versatility of the product makes it usable for people with minimal to severe impairments of functional capacity.

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?
37951	Handgrip disability-assistive walker, non-powered, foldable	A non-powered, all- or partially-wheeled mobility aid in the form of a waist-high, foldable framework with handgrips and three or four legs designed to provide a stable support for a patient with a walking disability, a geriatric, obese, or infirm patient when standing or ambulating; it may also be used during rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials and in the form of a mobile support structure which the patient holds and pushes in front of them as they walk. It is foldable for storage and transportation and may include a braking mechanism; it may be width-adjustable and some types may include a seat on which the patient can rest.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITJ	Walker, 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: 73c234b5-08bf-4ab0-8118-0ba34bfb4a76
Public Version Date: February 10, 2025
Public Version Number: 1
DI Record Publish Date: January 31, 2025