BEUDAMED
    FDA Registration Active 🇫🇷 France

    KeriFlex MCP and PIP Joint Prostheses

    Reg #: 1000286794 · FEI: 1000286794 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STERLAB
    Registration Number
    1000286794
    FEI Number
    1000286794
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2720 CHEMIN SAINT BERNARD
    City
    VALLAURIS Alpes-Maritimes
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K211385

    Owner / Operator

    Firm Name
    STERLAB
    Operator Number
    10042816
    Address
    2720 CHEMIN SAINT BERNARD
    City
    VALLAURIS
    State
    Alpes-Maritimes
    Postal Code
    06224
    Country
    FR
    Correspondent
    Nathalie MATOSSIAN

    US Agent

    Business Name
    STERICERT CO.
    Contact Name
    Jonathan A. WILDER
    Address
    301 City Ave. LL3
    City
    Bala Cynwyd
    State
    PA
    ZIP
    19004
    Country
    US
    Email
    [email protected]
    Phone
    267 2692779

    Products

    Device Name Product Code
    Prosthesis, Finger, Constrained, Polymer KYJ

    Proprietary Names

    KeriFlex MCP and PIP Joint Prostheses

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)