BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    PROFEMUR® PRESERVE STARTER BROACH (PRPRSTBR)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STRAITS ORTHOPAEDICS (MFG) SDN BHD
    Registration Number
    3012217062
    FEI Number
    3012217062
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No 2483 Tingkat Perusahaan 4A, Prai Free Industrial Zone
    City
    Perai Pulau Pinang
    Country
    MY

    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
    Broach HTQ

    Proprietary Names

    PROFEMUR® PRESERVE STARTER BROACH (PRPRSTBR) PROFEMUR® PRESERVE PILOTED MODULAR BROACH SIZE 1 (PRPRPB01) LARGE MIS BUNION BROACH AVG NON STERILE MIS BUNION (97700012) PROFEMUR® GLADIATOR® STARTER BROACH (PRGLSTBR) LARGE MIS BUNION BROACH MAX NON STERILE MIS BUNION (97700011) SMALL MIS BUNION BROACH AVG NON STERILE MIS BUNION (97700016) SMALL MIS BUNION BROACH MAX NON STERILE MIS BUNION (97700015) MED MIS BUNION BROACH AVG NON STERILE MIS BUNION (97700014) Empowr Partial Knee™ Distal Femoral Resection Guide, Std Offset (800-06-034) MED MIS BUNION BROACH MAX NON STERILE MIS BUNION (97700013) Long Broach 41mm (1230-4263) Long Broach 36mm (1230-4262) Short Broach 41mm (1230-4261) Center Drill Guide ASM (1230-5212) Short Broach 36mm (1230-4260) Disc 2.5mm Left Ulna Rasp (414867-001) Single Offset Broach Handle Assembly (201-1-10301) Desoutter Broach Adapter - Straight Assembly (201-1-10601) Desoutter Broach Adapter Assembly - Anterior Assembly (201-1-10600)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)