FDA.reportPublic FDA data

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810079192656Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192663Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192670Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192687Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192694Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192700Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192717Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192724Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192731Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192748Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192755Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192762Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192779Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192786Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192793Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192809Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192816Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192823Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192946Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192953Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192960Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192977Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192984Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192991Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079193004Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079193011Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079193028Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00636257213322MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213339MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213346MEDIMEDI MANUFACTURING, INC.IQI2026-04-24