BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Tap, 4.75mm Cortical, SNI1

    Reg #: 3009165919 · FEI: 3009165919 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Kalitec Direct LLC DBA Kalitec Medical
    Registration Number
    3009165919
    FEI Number
    3009165919
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    865 Oviedo Blvd, Suite 1017
    City
    Oviedo
    State
    FL
    ZIP
    32765
    Country
    US

    Owner / Operator

    Firm Name
    Kalitec Medical
    Operator Number
    10037099
    Address
    865 Oviedo Blvd, Suite 1017
    City
    Oviedo
    State
    FL
    Postal Code
    32765
    Country
    US

    Products

    Device Name Product Code
    Tap, Bone HWX

    Proprietary Names

    Tap, 4.75mm Cortical, SNI1 Tap, 8.5mm Cortical, SNI1

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility