BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    OTOSCOPE

    DI: B1623061 · Model: BTS-306 · BELLEGROVE MEDICAL SUPPLY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OTOSCOPE
    Primary DI
    B1623061
    Version / Model
    BTS-306
    Catalog Number
    FEDMEDMICFIOT_US
    Company Name
    BELLEGROVE MEDICAL SUPPLY, INC.
    Labeler DUNS
    141647094
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-27
    Public Version
    2
    Public Version Date
    2022-09-30
    Public Version Status
    Update
    Public Device Record Key
    8520af0f-badb-44b8-98fe-c519ee0b3afc
    Distribution End Date
    2022-09-30

    Device Description

    OTOSCOPE

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ERA Otoscope

    GMDN Terms

    Code Name
    12849 Otoscope, direct

    Identifiers

    Type ID
    Primary B1623061