Ambroise

Primary DI
08720299427747
Brand
Ambroise
Company
Ambroise Holland B.V.
Model
Dynko
Device description
Dynamic Clubfoot orthosis
Published
2023-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IQIOrthosis, Limb Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720299427747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720299427747087202994277478720299427747

GMDN Terms#

Term, Definition table
TermDefinition
Foot orthosisA device designed to encompass the whole or part of the foot, or designed as a plantar insert, and intended to provide rigid or semi-rigid correction of the foot for persons with orthopaedic deformities/injuries of the feet; it may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds. It is typically made of metal, synthetic, and/or textile materials and may include customizable plantar inserts. This is a single-patient use device that can be reapplied to the patient during the treatment period (reusable) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
418298394
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719327474440AmbroiseAmber Wrist2023-09-15
08720299427716AmbroiseADPO2023-09-15
08719327474402AmbroiseWEO2023-09-15
08719327474433AmbroiseGenux 22023-09-15
08720299427709AmbroiseUTX2023-09-15
08720299427723AmbroiseGenux2023-09-15
08720299427730AmbroiseRadix2023-09-15
08720299427754AmbroiseAmbroise Triplemode Armorthosis (ATA)2023-09-15
08720299427778AmbroiseW2CO2023-09-15
08720299427785AmbroiseWCO2023-09-15
08720299427792AmbroiseWSO2023-09-15

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