FDA.reportPublic FDA data

Ambroise

Primary DI
08720299427730
Brand
Ambroise
Company
Ambroise Holland B.V.
Model
Radix
Device description
Radix prosthetic component
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
08720299427730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720299427730087202994277308720299427730

GMDN Terms#

Term, Definition table
TermDefinition
External lower-limb prosthesis custom-assemblyA customized assembly of externally-applied prosthetic devices intended to replace, in part or total, one or more segment(s) and/or joint(s) of the lower limb after amputation (at any hip, knee, or ankle-foot level). The device is assembled and adjusted at the clinic for each patient by joining interface, functional, alignment, structural and finishing prosthetic components.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
418298394
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
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
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
00636257220733MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220740MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220757MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220764MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220771MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220788MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221358MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221365MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221372MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221389MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221396MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221402MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221419MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221426MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221433MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221440MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221457MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221464MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221471MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221488MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221495MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221501MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221563MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221570MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221587MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221594MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221600MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221617MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221624MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221631MEDIMEDI MANUFACTURING, INC.IQI2026-07-20