BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NA

    DI: 06959664900420 · Model: AG-5011-1812 · Hangzhou AGS MedTech Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    7
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NA
    Primary DI
    06959664900420
    Version / Model
    AG-5011-1812
    Company Name
    Hangzhou AGS MedTech Co., Ltd.
    Labeler DUNS
    542984702
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-23
    Public Version
    1
    Public Version Date
    2019-05-01
    Public Version Status
    New
    Public Device Record Key
    a65a6a56-2cac-4616-801a-a5a0da3ef44f

    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
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PKL Hemostatic Metal Clip For The Gi Tract

    GMDN Terms

    Code Name
    61207 Gastrointestinal endoscopic clip, short-term

    Identifiers

    Type ID
    Package 66959664900422
    Package 56959664900425
    Package 26959664900424
    Package 16959664900427
    Primary 06959664900420
    Package 46959664900428
    Package 36959664900421

    Premarket Submissions

    Submission Number Supplement Number
    K172727 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -10 – 40 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    – 80 Percent (%) Relative Humidity