BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Standard Bougie, SB38

    Reg #: 3012481535 · FEI: 3012481535 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    STANDARD BARIATRICS
    Registration Number
    3012481535
    FEI Number
    3012481535
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4300 Glendale Milford Road
    City
    Cincinnati
    State
    OH
    ZIP
    45242
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210437

    Owner / Operator

    Firm Name
    Teleflex
    Operator Number
    9062981
    Address
    3015 Carrington Mill Blvd.
    City
    Morrisville
    State
    NC
    Postal Code
    27560
    Country
    US
    Correspondent
    Divya Raman

    Products

    Device Name Product Code
    Tubes, Gastrointestinal (And Accessories) KNT

    Proprietary Names

    Standard Bougie, SB38

    Establishment Types

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