Home GUDID 00810113682532 ManaMed Inc
Primary DI 00810113682532
Brand ManaMed Inc
Company Manamed, Inc.
Model ManaEZ Ice Wrap Shoulder
Catalog number EZIWSHLDR01
Device description ManaEZ Ice Wrap Shoulder is a quick fitting, universal, shoulder orthosis. This shoulder brace also includes an ice pack.Removable ice packLightweight, latex free breathable materialEffortless application, universal size with hook and loop closureDesigned for either left or right shoulder
Published 2022-09-01
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true Product Codes# Code, Name table Code Name IQQ Joint, Shoulder, External Limb Component KYR Bag, Ice
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IQQ Joint, Shoulder, External Limb Component Physical Medicine 1 KYR Bag, Ice General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810113682532 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 00810113682532 00810113682532 810113682532 0810113682532
GMDN Terms# Term, Definition table Term Definition Shoulder support/thermal therapy bandage A non-sterile fabric material formed to fit around the shoulder and intended to provide pressure to support the joint following injury (e.g., sports injuries), disease (e.g., rheumatism), and/or surgery; it is designed to accommodate the insertion of a hot/cold pack(s) to provide heat or cold therapy for the skin and underlying tissues to facilitate the reduction of oedema and pain. The device typically includes fasteners; it may be used in a healthcare facility or at home. 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 00810113682730 ManaSlide MSLIDE MSLIDE01 2025-11-25 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
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