BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ace Medical

    DI: 00840217900270 · Model: ACE10-30T EX · Ebner Medical, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ace Medical
    Primary DI
    00840217900270
    Version / Model
    ACE10-30T EX
    Catalog Number
    ACE10-30T EX
    Company Name
    Ebner Medical, LLC
    Labeler DUNS
    106135367
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-29
    Public Version
    4
    Public Version Date
    2024-01-29
    Public Version Status
    Update
    Public Device Record Key
    03716329-2d84-47d2-bc9f-8223bda052fd

    Device Description

    Ceramic Kerrison Rongeur 10", 3.0mm tip with ejector thin Footplate

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HAE Rongeur, Manual

    GMDN Terms

    Code Name
    35541 Spinal rongeur

    Identifiers

    Type ID
    Primary 00840217900270

    Customer Contacts

    Phone
    800-822-0314
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K200387 000

    Device Sizes

    Type Value Unit Text
    Length 10 Inch
    Width 3 Millimeter