BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    REFOBACIN® BONE CEMENT R

    DI: 00880304990203 · Model: 110034356 · BIOMET
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    REFOBACIN® BONE CEMENT R
    Primary DI
    00880304990203
    Version / Model
    110034356
    Catalog Number
    110034356
    Company Name
    BIOMET
    Labeler DUNS
    260930126
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-30
    Public Version
    3
    Public Version Date
    2020-06-19
    Public Version Status
    Update
    Public Device Record Key
    908d2fc6-03ee-40da-9431-d08cfe32e3da

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    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
    LOD BONE CEMENT
    MBB BONE CEMENT, ANTIBIOTIC

    GMDN Terms

    Code Name
    46059 Orthopaedic cement, antimicrobial

    Identifiers

    Type ID
    Primary 00880304990203

    Customer Contacts

    Phone
    +0330475759100
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K171540 000