BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RIGID SHEATH FOR LTF-190-10-3D

    DI: 04953170340741 · Model: MAJ-2079 · OLYMPUS MEDICAL SYSTEMS CORP.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RIGID SHEATH FOR LTF-190-10-3D
    Primary DI
    04953170340741
    Version / Model
    MAJ-2079
    Company Name
    OLYMPUS MEDICAL SYSTEMS CORP.
    Labeler DUNS
    711789789
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    6
    Public Version Date
    2019-03-11
    Public Version Status
    Update
    Public Device Record Key
    0ac541db-e251-4794-9b67-c52108982c8f

    Device Characteristics

    Single Use
    No
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Ethylene Oxide", "High-level Disinfectant", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    GCJ Laparoscope, general & plastic surgery
    HET LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

    GMDN Terms

    Code Name
    37086 Endoscope sheath, reusable

    Identifiers

    Type ID
    Primary 04953170340741

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K955403 000