BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    External Marker Cover B

    DI: 04953170077753 · Model: MAJ-998 · OLYMPUS MEDICAL SYSTEMS CORP.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    External Marker Cover B
    Primary DI
    04953170077753
    Version / Model
    MAJ-998
    Company Name
    OLYMPUS MEDICAL SYSTEMS CORP.
    Labeler DUNS
    711789789
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-12-16
    Public Version
    3
    Public Version Date
    2023-01-16
    Public Version Status
    Update
    Public Device Record Key
    b1ae1c5d-7cba-49d4-8d5b-8db858a80690
    Distribution End Date
    2022-08-09

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    No
    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
    PGU Spatial Imaging For Display Of Endoscope Position
    FDF Colonoscope And Accessories, Flexible/Rigid

    GMDN Terms

    Code Name
    44924 Gastrointestinal catheter/endoscope tracking system

    Identifiers

    Type ID
    Primary 04953170077753

    Customer Contacts

    Phone
    +1(800)401-1086
    Email
    [email protected]