BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    AccuFilm®

    DI: M595S0501 · Model: Arch · PARKELL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    72

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    AccuFilm®
    Primary DI
    M595S0501
    Version / Model
    Arch
    Catalog Number
    S050
    Company Name
    PARKELL, INC.
    Labeler DUNS
    009900424
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    72
    Record Status
    Published
    Publish Date
    2018-10-12
    Public Version
    2
    Public Version Date
    2019-04-01
    Public Version Status
    Update
    Public Device Record Key
    3459f735-a0d1-4508-9374-8d1183a7f802
    Distribution End Date
    2019-01-01

    Device Description

    AccuFilm® Arch Marking Paper- Red/Blue

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    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
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EFH Paper, Articulation

    GMDN Terms

    Code Name
    16181 Dental articulation paper

    Identifiers

    Type ID
    Primary M595S0501
    Unit of Use M595S0500

    Customer Contacts

    Phone
    6312491134
    Email
    [email protected]