BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OPTICS ONE

    DI: 00815384022377 · Model: 9955-50 · MEDICAL TECHNIQUE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OPTICS ONE
    Primary DI
    00815384022377
    Version / Model
    9955-50
    Catalog Number
    9955-50
    Company Name
    MEDICAL TECHNIQUE, INC.
    Labeler DUNS
    790514756
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    7f92d6b4-4006-4afc-89f8-8c68776f8e9b

    Device Description

    X-ray Cassette Cover 20 x 40 Fold and Tuck Closure

    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
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    KKX Drape, Surgical

    GMDN Terms

    Code Name
    45021 Instrument/equipment drape, single-use, sterile

    Identifiers

    Type ID
    Package 00815384022391
    Package 00815384022384
    Primary 00815384022377

    Customer Contacts

    Phone
    520-733-7999
    Email
    [email protected]