FDA.report

CLIP

Primary DI
08055715704844
Brand
CLIP
Company
ORMESA SRL
Model
CLIP-3
Device description
Foldable pushchair/seating system intended for children and young people with functional deficits in walking and / or other disabilities 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.
Published
2025-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
INMChair, With Casters

Product Code Classifications

CodeDeviceSpecialtyClass
INMChair, With CastersPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08055715704844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08055715704844080557157048448055715704844

GMDN Terms

TermDefinition
Assistive pushchairA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
432070019
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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