FDA.reportPublic FDA data

Ambroise

Primary DI
08719327474440
Brand
Ambroise
Company
Ambroise Holland B.V.
Model
Amber Wrist
Device description
Dynamic Wrist Orthosis
Published
2023-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IRAHand, External Limb Component, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRAHand, External Limb Component, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719327474440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719327474440087193274744408719327474440

GMDN Terms#

Term, Definition table
TermDefinition
Wrist orthosisA prefabricated (non-customized) externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the wrist. This is a reusable device.

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
08720299427716AmbroiseADPO2023-09-15
08719327474402AmbroiseWEO2023-09-15
08719327474433AmbroiseGenux 22023-09-15
08720299427709AmbroiseUTX2023-09-15
08720299427723AmbroiseGenux2023-09-15
08720299427730AmbroiseRadix2023-09-15
08720299427747AmbroiseDynko2023-09-15
08720299427754AmbroiseAmbroise Triplemode Armorthosis (ATA)2023-09-15
08720299427778AmbroiseW2CO2023-09-15
08720299427785AmbroiseWCO2023-09-15
08720299427792AmbroiseWSO2023-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04719883463524TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IRA2025-01-10
04719883463531TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IRA2025-01-10
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