Home GUDID 00810113683898 FlexSafe Ankle Recovery Orthosis, Large
Primary DI 00810113683898
Brand FlexSafe Ankle Recovery Orthosis, Large
Company Manamed, Inc.
Model EZARO-01L
Catalog number EZARO-01L
Device description The FlexSafe Ankle Recovery Orthosis is a tall pneumatic walker boot built with a unique rocker bottom to simulate natural gait and is open on the medial/lateral sides. Athletic bottom designLarge air bladder creates a larger surface for contact pressure to control swelling and ensure snug fitOpen sides to allow for less friction on surgical incision sites 4 D-ring hook and loop closures
Published 2025-10-31
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true Product Codes# Code, Name table Code Name ITW Joint, Ankle, External Brace
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ITW Joint, Ankle, External Brace Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810113683898 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810113683898 00810113683898 810113683898 0810113683898
GMDN Terms# Term, Definition table Term Definition Cast boot A boot-like device designed to be attached around a leg cast to protect and support the cast, and to assist with patient mobility. This device is generally equipped with a waterproof covering, an outer sole for walking, and closures for easy application and removal. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
Regulatory Flags# DUNS number 084042331 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810113688473 ManaMed Inc ManaMed Ultrasound Coupling Gel MANAGEL01 2022-12-31 00810113684154 ManaEZ Wrist Left, Extra Large EZW3908L-XL EZW3908L-XL 2025-10-17 00810113684161 ManaEZ Wrist Left, Extra Small EZW3908L-XS EZW3908L-XS 2025-10-17 00810113684178 ManaEZ Wrist Right, Extra Large EZW3908R-XL EZW3908R-XL 2025-10-17 00810113684185 ManaEZ Wrist Right, Extra Small EZW3908R-XS EZW3908R-XS 2025-10-17 00810113682969 "ManaEZ Single Panel Knee Immobilizer 18""" EZIMM01-18 EZIMM01-18 2025-11-25 00810113682976 "ManaEZ Single Panel Knee Immobilizer 20""" EZIMM01-20 EZIMM01-20 2025-11-25 00810113682983 "ManaEZ Single Panel Knee Immobilizer 24""" EZIMM01-24 EZIMM01-24 2025-11-25 00810113682990 "ManaEZ 3 Panel Knee Immobilizer 18""" EZ3PIMM01-18 EZ3PIMM01-18 2025-11-25 00810113683003 "ManaEZ 3 Panel Knee Immobilizer 20""" EZ3PIMM01-20 EZ3PIMM01-20 2025-11-25 00810113683010 "ManaEZ 3 Panel Knee Immobilizer 24""" EZ3PIMM01-24 EZ3PIMM01-24 2025-11-25 00810113683294 "ManaEZ 3 Panel Knee Immobilizer 16""" EZ3PIMM01-16 EZ3PIMM01-16 2025-11-25 00810113682600 ManaMed Inc ManaEZ Ice Wrist EZIWST01 2022-10-13 00850998008119 ManaMed ManaEZ Wrist Universal Right EZW3908R 2022-06-20 00850998008126 ManaMed ManaEZ Wrist Universal Left EZW3908L 2022-06-20 00810113683065 ManaEZ ROM Ice Short EZR001-XSM EZR001-XSM 2025-10-17 00810113683515 ManaEZ Hip Ice CureTech EZHIP01B-CT EZHIP01B-CT 2025-10-03 00810113683522 ManaEZ ROM Ice CureTech EZR001-CT EZR001-CT 2025-10-03 00810113683539 ManaEZ Shoulder Ice CureTech EZSHLD-CT EZSHLD-CT 2025-10-03 00810113683577 ManaEZ Ice Long Duration Knee EZLDIP-KN EZLDIP-KN 2025-11-25
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