BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    X-Tack Endoscopic HeliX Tacking System

    DI: 10811955020756 · Model: CNH-C01-213-L · Apollo Endosurgery, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    6

    Basic Information

    Brand Name
    X-Tack Endoscopic HeliX Tacking System
    Primary DI
    10811955020756
    Version / Model
    CNH-C01-213-L
    Catalog Number
    CNH-C01-213-L
    Company Name
    Apollo Endosurgery, Inc.
    Labeler DUNS
    625064352
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2021-07-12
    Public Version
    2
    Public Version Date
    2023-05-15
    Public Version Status
    Update
    Public Device Record Key
    864c5919-8903-460f-ba9b-92c33cd5b4ca

    Device Description

    Suture Cinch - Long

    Device Characteristics

    Single Use
    Yes
    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
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    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
    PKL Hemostatic Metal Clip For The Gi Tract
    OCW Endoscopic Tissue Approximation Device

    GMDN Terms

    Code Name
    61207 Gastrointestinal endoscopic clip, short-term

    Identifiers

    Type ID
    Package 20811955020753
    Primary 10811955020756
    Unit of Use 00811955020759

    Customer Contacts

    Phone
    855-551-3123
    Email
    [email protected]