BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    RAYHACK™ CORT SCR 3.5MM,12MMSS

    Reg #: 3004889950 · FEI: 3004889950 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    30
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Straits Orthopaedics (MFG) Sdn Bhd
    Registration Number
    3004889950
    FEI Number
    3004889950
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2, Lengkok Teluk Kumbar 1, Jalan Teluk Kumbar
    City
    Bayan Lepas Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K061955

    Owner / Operator

    Firm Name
    Straits Orthopaedics (Mfg) Sdn Bhd
    Operator Number
    10048319
    Address
    No. 2 Lengkok Teluk Kumbar, Jalan Teluk Kumbar
    City
    Bayan Lepas
    State
    Pulau Pinang
    Postal Code
    11920
    Country
    MY
    Correspondent
    TH SU

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS

    Proprietary Names

    RAYHACK™ CORT SCR 3.5MM,12MMSS RAYHACK™ CORT SCR 3.5MM, 22MMTI RAYHACK™ CORT SCR 3.5MM, 24MMTI RAYHACK™ CORT SCR 2.7MM,12MMTI RAYHACK™ CORT SCR 2.7MM,24MMSS RAYHACK™ CORT SCR 3.5MM,20MMSS RAYHACK™ CORT SCR 3.5MM,16MMSS RAYHACK™ CORT SCR 2.7MM,20MMTI RAYHACK™ CORT SCR 3.5MM,24MMSS RAYHACK™ CORT SCR 3.5MM,22MMSS RAYHACK™ CORT SCR 2.7MM,14MMSS RAYHACK™ CORT SCR 2.7MM,14MMTI RAYHACK™ CORT SCR 2.7MM, 20MMSS RAYHACK™ CORT SCR 3.5MM,10MMSS RAYHACK™ CORT SCR 3.5MM,18MMTI RAYHACK™ CORT SCR 3.5MM,18MMSS RAYHACK™ CORT SCR 3.5MM,16MMTI RAYHACK™ CORT SCR 3.5MM,12MMTI RAYHACK™ CORT SCR 2.7MM,10MMTI RAYHACK™ CORT SCR 2.7MM,18MMSS RAYHACK™ CORT SCR 2.7MM,16MMSS RAYHACK™ CORT SCR 3.5MM,14MMSS RAYHACK™ CORT SCR 2.7MM,22MMSS RAYHACK™ CORT SCR 3.5MM,14MMTI RAYHACK™ CORT SCR 2.7MM,10MMSS RAYHACK™ CORT SCR 2.7MM,18MMTI RAYHACK™ CORT SCR 2.7MM,16MMTI RAYHACK™ CORT SCR 2.7MM,12MMSS RAYHACK™ CORT SCR 3.5MM,10MMTI RAYHACK™ CORT SCR 3.5MM, 20MMTI

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)