BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AMSure® Irrigation Tray with Bulb Syringe

    DI: 10704411008101 · 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® Irrigation Tray with Bulb Syringe
    Primary DI
    10704411008101
    Version / Model
    1
    Catalog Number
    AS130
    Company Name
    AMSINO INTERNATIONAL, INC.
    Labeler DUNS
    825673239
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-05-30
    Public Version
    3
    Public Version Date
    2018-11-30
    Public Version Status
    Update
    Public Device Record Key
    5a83f6a9-c8d2-4b6a-bfdb-4fdfaa122c8e

    Device Description

    AMSure® Irrigation Tray with Bulb Syringe CONTENTS: 1 each 1000 cc Outer Tray 1 each 500 cc Graduated Container 1 each 60 cc Bulb Irrigation Syringe 1 each Tip Protector 1 each Alcohol Prep Pad 1 each Large Moisture-Proof Underpad

    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
    32043 Laparoscopic surgical procedure kit, non-medicated, reusable

    Identifiers

    Type ID
    Package 40704411008102
    Primary 10704411008101