BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ESI

    DI: B396154011O0 · Model: 15-4011O · FTT MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ESI
    Primary DI
    B396154011O0
    Version / Model
    15-4011O
    Company Name
    FTT MEDICAL, INC.
    Labeler DUNS
    002212793
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-14
    Public Version
    4
    Public Version Date
    2023-11-17
    Public Version Status
    Update
    Public Device Record Key
    d531d569-7acc-495d-988a-be0d08745e89

    Device Description

    REPLACEMENT OBTURATOR ONLY FOR 12CM STAINLESS SALVATI.

    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
    No
    PM Exempt
    Yes
    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
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    GCF Proctoscope

    GMDN Terms

    Code Name
    35255 Optical proctoscope, reusable

    Identifiers

    Type ID
    Primary B396154011O0