BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SureClip

    DI: 46932503530185 · Model: ROCC-C-26-165-C · Micro-Tech (Nanjing) Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SureClip
    Primary DI
    46932503530185
    Version / Model
    ROCC-C-26-165-C
    Catalog Number
    ROCC-C-26-165-C
    Company Name
    Micro-Tech (Nanjing) Co., Ltd.
    Labeler DUNS
    530269083
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-03-18
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    ce0b6948-cf65-4c3d-a8d0-50f33ebb2fc7

    Device Description

    Open width8±1.5mm the max OD of insertion part 2.6mm working length 1650mm coated, 2 pcs in the box

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    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 66932503530189
    Package 56932503530182
    Primary 46932503530185

    Premarket Submissions

    Submission Number Supplement Number
    K152001 000