BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AMSure® EAR/ULCER SYRINGE

    DI: 10704411008347 · Model: 1 · AMSINO INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AMSure® EAR/ULCER SYRINGE
    Primary DI
    10704411008347
    Version / Model
    1
    Catalog Number
    AS00501S
    Company Name
    AMSINO INTERNATIONAL, INC.
    Labeler DUNS
    825673239
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-06-05
    Public Version
    2
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    03673bb3-0293-410c-8547-98e4b4d5d145

    Device Description

    AMSure® EAR/ULCER SYRINGE 1 oz

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KYZ Syringe, Irrigating (Non Dental)

    GMDN Terms

    Code Name
    35025 Ear canal irrigation syringe

    Identifiers

    Type ID
    Package 40704411008348
    Primary 10704411008347