AccessGUDID - DEVICE: CLIP (08055715704851)

GUDID

Device Identifier (DI) Information

Brand Name: CLIP
Version or Model: CLIP-4
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORMESA SRL

Primary DI Number: 08055715704851
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432070019 *Terms of Use

Device Description: Foldable pushchair intended for teens and adults with functional deficits in walking, who do not need a postural system that can be adapted to the patient. It is suitable for users who need a minimum containment at the level of the trunk and head, useful for positioning on the stroller in short / medium trips.

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: b0445f1b-13eb-42ba-95b5-8887ecadfb00
Public Version Date: February 10, 2025
Public Version Number: 1
DI Record Publish Date: January 31, 2025