FDA.reportPublic FDA data

Ambroise

Primary DI
08719327474433
Brand
Ambroise
Company
Ambroise Holland B.V.
Model
Genux 2
Device description
Knee Orthosis (Gen.2)
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
08719327474433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719327474433087193274744338719327474433

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made lower-limb orthosisAn externally-applied wearable appliance constructed with specific characteristics (e.g., size, shape, material), as prescribed by a healthcare provider for a specified patient (custom-made), intended to support and correct deformities of the leg and/or feet. It may be one of numerous different designs and is typically made of synthetic and textile materials. This is a single-patient reusable device.

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
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
00636257215913MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00636257215920MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00636257215937MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00636257215944MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00636257215951MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00636257215968MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00190446660590PROCAREDJO, LLCIQI2026-07-31
00190446660606PROCAREDJO, LLCIQI2026-07-31
00190446660613PROCAREDJO, LLCIQI2026-07-31
00190446660620PROCAREDJO, LLCIQI2026-07-31
00190446660637PROCAREDJO, LLCIQI2026-07-31
00190446660644PROCAREDJO, LLCIQI2026-07-31
00810178883127ViveVIVE HEALTH LLCIQI2026-07-21
00810178883134ViveVIVE HEALTH LLCIQI2026-07-21
00810178883141ViveVIVE HEALTH LLCIQI2026-07-21
00810178883158ViveVIVE HEALTH LLCIQI2026-07-21
00400000326986MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000326993MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327006MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327013MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327020MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327037MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327044MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327051MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327068MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327075MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327082MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327099MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327105MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327112MEDIMEDI MANUFACTURING, INC.IQI2026-07-20