AccessGUDID - DEVICE: BIRILLO (08055715701171)

GUDID

Device Identifier (DI) Information

Brand Name: BIRILLO
Version or Model: BIRILLO-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORMESA SRL

Primary DI Number: 08055715701171
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432070019 *Terms of Use

Device Description: Walking fram from a seated position, intended for all those children from 70 to 140 cm height, with functional deficits who need containment a pelvis level (in particular) and trunk level, through the classic “Bobath angle” and that, through the use of "stepping" made possible by the presence of the wheels under the seat, are able to move into the surrounding environment and explore it, becoming a significant stimulus towards greater autonomy. To use the walker, the user needs sufficient strength in the upper and lower limbs, Ability to transfer the load from one limb to another, Head and trunk control, Minimum flexion of the elbows 15-20°, 90° hip flexion.

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?
38704	Walking chair, non-foldable	An all-wheeled mobility aid in the form of a non-foldable framework that has a built-in seat or sling that supports a disabled or geriatric person in a sitting position while walking. It is constructed of lightweight metal, plastic, rubber and textile materials in the shape of a low centre-of-gravity mobile support structure in which the user walks while seated. The device is non-foldable and may include forearm supports and a braking mechanism.	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: 97f31d65-3f15-4f15-a7c7-588c9eb93e30
Public Version Date: February 10, 2025
Public Version Number: 1
DI Record Publish Date: January 31, 2025