BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BENCOX Bipolar Cup System

    DI: 08806373869372 · Model: H2.A51.0046-01 · Corentec Co., Ltd
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BENCOX Bipolar Cup System
    Primary DI
    08806373869372
    Version / Model
    H2.A51.0046-01
    Company Name
    Corentec Co., Ltd
    Labeler DUNS
    688739895
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-09
    Public Version
    1
    Public Version Date
    2020-04-17
    Public Version Status
    New
    Public Device Record Key
    1f51524f-41d9-41cf-bbf2-d65792196010

    Device Description

    BENCOX Bipolar Cup 46mm-Insert

    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
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    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
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

    GMDN Terms

    Code Name
    33175 Metallic femoral head prosthesis

    Identifiers

    Type ID
    Primary 08806373869372

    Customer Contacts

    Phone
    +82415857114
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K112019 000