Home GUDID 08719327474433 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 Code Name IQI Orthosis, Limb Brace
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IQI Orthosis, Limb Brace Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08719327474433 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08719327474433 08719327474433 8719327474433
GMDN Terms# Term, Definition table Term Definition Custom-made lower-limb orthosis An 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.
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810178883127 Vive VIVE HEALTH LLC IQI 2026-07-21 00810178883134 Vive VIVE HEALTH LLC IQI 2026-07-21 00810178883141 Vive VIVE HEALTH LLC IQI 2026-07-21 00810178883158 Vive VIVE HEALTH LLC IQI 2026-07-21 00400000326986 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000326993 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327006 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327013 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327020 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327037 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327044 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327051 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327068 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327075 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327082 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327099 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327105 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327112 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327129 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327136 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327143 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327150 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327167 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327174 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327181 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327198 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327204 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327211 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327228 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327235 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20