AccessGUDID - DEVICE: TROLLINO (08055715707838)

GUDID

Device Identifier (DI) Information

Brand Name: TROLLINO
Version or Model: TROLLINO PINK with 951 Height adjustable push handles
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORMESA SRL

Primary DI Number: 08055715707838
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432070019 *Terms of Use

Device Description: TROLLINO is an assistive device for children and teens (95 - 140 cm tall) that need a system for mobility during everyday activities, with different levels of functional and postural needs. It allows the positioning of the user with disabilities of various complexity in the most appropriate and functional posture to the different contexts of daily life. The postural options (padded covers, harnesses, belts) allow to give stability to the pelvis, lower limbs, trunk and head, and to take different positions thanks to the reclining of the backrest. It can therefore be also used in medium gravity circumstances, in outdoor environments, for the transport of those users who are not able to maintain their sitting posture, due to severe diseases of the nervous system, of the muscular apparatus or relational 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: e5bc1a03-bd11-45b2-9fb4-87b8af9d2b24
Public Version Date: February 10, 2025
Public Version Number: 1
DI Record Publish Date: January 31, 2025