BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    RF-DRILL-50 Redemption Pre-Drill, Cannulated Beam 4mm, Large Hudson QC

    Reg #: 3025603301 · FEI: 3025603301 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    35
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STRAITS ORTHOPAEDICS (MFG) SDN BHD
    Registration Number
    3025603301
    FEI Number
    3025603301
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1264, Lorong PSPN 1, Penang Science Park North
    City
    Simpang Ampat Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K221342

    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
    Screw, Fixation, Bone HWC

    Proprietary Names

    RF-DRILL-50 Redemption Pre-Drill, Cannulated Beam 4mm, Large Hudson QC RF-T25 Redemption Cannulated T25 Driver RF-GUIDE-64-S 6.4mm Drill Sleeve K230-22S Redemption Trocar Wire RF-PSHR-W Redemption K-Wire Pusher RF-T15 Redemption Cannulated T15 Straight Driver RF-GUIDE-6469-H Handle 2 Sided RF-GUIDE-40-H One Sided Handle RF-DRILL-35 Redemption ,Drill 2.8mm , for 3.5mm Cross Screw RF-HLDR Redemption Implant Holder RF-GD-AS Redemption. Guide Assembly RF-GUIDE-S Redemption,Guide Sleeve RF-GD-P Guide Plastic Component RF-DPTH Redemption,Depth Gauge, Long Screws RF-LN-12 Redemption,Nut, Locking, M12 Version RF-GUIDE-69-S 6.9mm Drill Sleeve RF-GUIDE-5260 Redemption,Drill Guide,5.2mm and 6mm RF-GUIDE-6469 Redemption Drill Guide, 6.4mm & 6.9mm RF-GUIDE-52-S 5.2mm Drill Sleeve RF-HLDR-LS Redemption, Locking Screw,12mm RF-GUIDE-5260-H Drill Protector Handle Two Sided RF-GD-P1 941" X .25" Dowel Pin RF-GUIDE-60-S 6MM Drill Sleeve RF-DRILL-80 Redemption Pre-Drill, Cannulated Beam 6mm, Large Hudson QC RF-PSHR-W-001 Pusher Handle RF-GUIDE-40-S 4mm Drill Sleeve RF-DRILL-65 Redemption Pre-Drill, Cannulated Beam 5.2mm, Large Hudson QC RF-DRVR-AD Redemption,Nail Driver RF-DRILL-82 Redemption Pre-Drill, Cannulated Beam 6.9mm, Large Hudson QC RF-GUIDE Redemption, Drill Guide RF-DRILL-75 Redemption Pre-Drill, Cannulated Beam 6.4mm, Large Hudson QC RF-GD-P2 Diameter 941" X .600" Dowel RF-GUIDE-40 Redemption Drill Guide, 4mm RF-PSHR-W-002 Pusher Wire RF-GD-M Guide Metal Component

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)