BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 04961333245192 · Model: 7190-5300 · PENTAX OF AMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    N/A
    Primary DI
    04961333245192
    Version / Model
    7190-5300
    Company Name
    PENTAX OF AMERICA, INC.
    Labeler DUNS
    083211284
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-04-03
    Public Version
    1
    Public Version Date
    2018-05-04
    Public Version Status
    New
    Public Device Record Key
    ce0d053a-db38-4e5b-ae54-b0f624480af0

    Device Description

    MIC PRE-AMP KIT (ROLLS MP-13)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OUG Medical Device Data System

    GMDN Terms

    Code Name
    30076 Voice amplification system

    Identifiers

    Type ID
    Primary 04961333245192