BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Elements by Hedy Barrier Envelopes

    DI: D903HEBEHO1 · Model: HE-BEHO1 · AMD Medicom Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Elements by Hedy Barrier Envelopes
    Primary DI
    D903HEBEHO1
    Version / Model
    HE-BEHO1
    Catalog Number
    HE-BEHO1
    Company Name
    AMD Medicom Inc
    Labeler DUNS
    256880576
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-18
    Public Version
    2
    Public Version Date
    2020-07-16
    Public Version Status
    Update
    Public Device Record Key
    1423c391-9460-4309-9dc5-ed82290320f6

    Device Description

    Dental Barrier Sleeves for Phosphor Storage, Size Medium

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PEM Dental Barriers And Sleeves

    GMDN Terms

    Code Name
    45256 Digital imaging cassette/storage phosphor screen, dental

    Identifiers

    Type ID
    Package D903HEBEHO11
    Primary D903HEBEHO1