Home GUDID 08719327474402 Ambroise
Primary DI 08719327474402
Brand Ambroise
Company Ambroise Holland B.V.
Model WEO
Device description Arm orthosis with flexion support
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 IRA Hand, External Limb Component, Mechanical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IRA Hand, External Limb Component, Mechanical Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08719327474402 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08719327474402 08719327474402 8719327474402
GMDN Terms# Term, Definition table Term Definition Custom-made upper-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 arm and/or hand. 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 04719883463494 TEHLIN TEH LIN PROSTHETIC & ORTHOPAEDIC INC. IRA 2025-01-10 04719883463500 TEHLIN TEH LIN PROSTHETIC & ORTHOPAEDIC INC. IRA 2025-01-10 04719883463517 TEHLIN TEH LIN PROSTHETIC & ORTHOPAEDIC INC. IRA 2025-01-10 04719883463524 TEHLIN TEH LIN PROSTHETIC & ORTHOPAEDIC INC. IRA 2025-01-10 04719883463531 TEHLIN TEH LIN PROSTHETIC & ORTHOPAEDIC INC. IRA 2025-01-10 00713980001331 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980001348 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980001355 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980001362 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980001379 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980001386 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980001393 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980001409 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980001416 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980001423 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980001430 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980001447 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980004332 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980004615 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980005131 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980005148 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980005179 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980005384 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980006008 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980006015 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980006046 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980008620 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980008637 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980008644 LOCK DEVICES Alps South, LLC IRA 2024-12-30 00713980008651 LOCK DEVICES Alps South, LLC IRA 2024-12-30