BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MULTI ADJUSTABLE FACEMASK

    DI: D90955010401 · Model: REPLACEMENT PADS · Ortho Arch Company Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MULTI ADJUSTABLE FACEMASK
    Primary DI
    D90955010401
    Version / Model
    REPLACEMENT PADS
    Catalog Number
    550-104
    Company Name
    Ortho Arch Company Inc
    Labeler DUNS
    020956330
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-15
    Public Version
    1
    Public Version Date
    2022-04-25
    Public Version Status
    New
    Public Device Record Key
    30b852ea-62ea-49f6-84d9-9ee6bedfb29d

    Device Description

    REPLACEMENT PADS FOR MULTI ADJUSTABLE FACEMASK

    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
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EIG Retractor, All Types

    GMDN Terms

    Code Name
    41067 Orthodontic chin cap/cup

    Identifiers

    Type ID
    Primary D90955010401