AccessGUDID - DEVICE: TROLLI (08055715707753)

GUDID

Device Identifier (DI) Information

Brand Name: TROLLI
Version or Model: TROLLI T60 MIS.43 DA AUTOSPINTA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORMESA SRL

Primary DI Number: 08055715707753
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432070019 *Terms of Use

Device Description: TROLLI is a wheelchair designed to facilitate the displacement of adults and children with walking issues: subjects with pathological pictures that do not require specific postural measures and that do not have complete autonomy. It allows the positioning of the user with disabilities of varying complexity, in the most appropriate and functional posture in the different everyday environments. The postural components (supports and belts) allow to give stability to the pelvis, lower limbs and trunk. It can be used even in medium severity circumstances, in outdoor and indoor environments, for the transport of those subjects, who are not able to independently maintain the seating posture due to severe disorders of the nervous and muscle system or of the rational sphere.

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?
31162	Assistive pushchair	A wheeled mobility device manually propelled by an attendant that consists of a open framework with one or more handle(s) designed to carry one or more person(s) with a disability in a seated or semi-lying (semi-recumbent) position.	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: a147beb0-3b80-44c6-9f92-1d3bd024306e
Public Version Date: February 10, 2025
Public Version Number: 1
DI Record Publish Date: January 31, 2025