BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ManaMed

    DI: 00810113680453 · Model: ManaEZ Collar 74 · MANAMED INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ManaMed
    Primary DI
    00810113680453
    Version / Model
    ManaEZ Collar 74
    Catalog Number
    EZC074
    Company Name
    MANAMED INC
    Labeler DUNS
    084042331
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-06-20
    Public Version
    1
    Public Version Date
    2022-06-28
    Public Version Status
    New
    Public Device Record Key
    4db6d3c5-f9d9-4292-8381-8a1b24545db6

    Device Description

    The brace is intended exclusively for orthotic fittings of the cervical spine and exclusively for contact with intact skin. The brace must be used in accordance with indications determined by a physician. Designed for comfort and performance Two-piece design for easy fitting and adjusting Made with vented and breathable linter 9 different adjustment settings

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IQK Orthosis, Cervical

    GMDN Terms

    Code Name
    41039 Cervical spine collar, reusable

    Identifiers

    Type ID
    Primary 00810113680453