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    FDA Registration Active 🇲🇾 Malaysia

    INTERTAN MAX 10.5MM LAG SCREW DRILL (REUSEABLE) (81122696)

    Reg #: 3033509898 · FEI: 3033509898 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    100
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STRAITS ORTHOPAEDICS (MFG) SDN BHD
    Registration Number
    3033509898
    FEI Number
    3033509898
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PMT 850, Persiaran Cassia Selatan 8,, Taman Perindustrian Batu Kawan,
    City
    Bandar Cassia 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
    Bit, Drill HTW

    Proprietary Names

    INTERTAN MAX 10.5MM LAG SCREW DRILL (REUSEABLE) (81122696) 5.5mm Pilot Drill Tiger Large Cannulated Screw System 215-55-001 Malleolus Implant Countersink 340-45-002 4mm Arsenal Screw Drill Bit Arsenal 340-40-001 2.7 mm Over Drill Bit Arsenal 330-27-011 2.7mm Arsenal Drill Arsenal 330-27-013 4 Cannulated Drill Bit 211-40-001 2.7mm Arsenal Screw Overdrill Bit Arsenal 340-27-011 3.5mm Arsenal Screw Overdrill Bit Arsenal 340-35-011 Consensus Sapphire Nail System Comp Bur 3.1mm x 13mm Foot SS 57SR3113 (153941) Lis Franc Drill Bit 4.5mm 43514500 Comp Bur 2mm X 8mm Foot SS 57SC2008 (153937) Comp Bur 2mm X 20mm Foot SS 57SC2020 (153939) MICA Burr 2 x 8mm Sterile Mica (57SR0208) Shannon Recta Burr 2 x 20mm Sterile Mica (57SR0220) One Step Drill Bit 2.2 x 12mm Sterile Cannulated DHVS0022 One Step Drill Bit 2.2 x 22mm Sterile Cannulated DHVS0L22 Drill Bit 2.2mm Solid Long Sterile MICA 57S1L122 MICA Burr 3 x 20mm (57SC0320) Comp Bur 2mm X 12mm Foot SS (57SC2012 (153938)) 2.8mm Drill Salvation™ MidFoot Nail (SMN10010) MICA Burr 2 x 12mm Sterile Mica (57SR0212) Surgibit® 4.5mm 3-Fluted SQC Drill Bit, 145mm Blank (10-4545145) Comp Bur 3mm X 20mm Foot SS 57SCL320 (153940) 8MM STEP DRILL (SMN10018) COMP CANN DRL 2.55MM (154971) Surgibit® 3.2mm 3-Fluted SQC Drill Bit, 230mm Blank (10-3230230) STEP DRILL 1.8 X 22MM (D001822N) 1.4 FO Micro Drill (Cannulated) (MSDR-1420) Surgibit® 2.5mm 3-Fluted SQC Drill Bit, 145mm Blank (10-2530145) 1.1 FO Micro Drill (MSDR-1115) 2.65MM CANNULATED DRILL INSERT (154972) COMP CANN DRL 2.2MM (154969) Surgibit® 5mm 3-Fluted SQC Drill Bit, 145mm Blank (10-5045145) Surgibit® 2.7mm 3-Fluted SQC Drill Bit, 145mm Blank (10-2730145) Surgibit® 2.5mm 3-Fluted SQC Drill Bit, 230mm Blank (10-2530230) Surgibit® 4.2mm 3-Fluted SQC Drill Bit, 145mm Blank (10-4230145) Surgibit® 4mm 3-Fluted SQC Drill Bit, 230mm Blank (10-4030230) Surgibit® 4mm 3-Fluted SQC Drill Bit, 145mm Blank (10-4030145) Comp Drl 2.5mm Insrt Foot SS Mcm (156108) 2.4mm X 3.5" FLUTED DRILL BIT (351-190-01) COMP CANN DRL 2.45MM (154970) Drill Bit 4.9mm Cann (D0149C2N) Step Drill 2.2 X 12mm (D002212N) 57S0L122 Drill Bit 2.2mm Solid Long Sterile MICA Surgibit® 2mm 3-Fluted SQC Drill Bit, 145mm Blank (10-2030145) Step Drill 2.2 x 22mm Sterile (D002222S) STEP DRILL 2.2 X 12MM STERILE (D002212S) 58RSPH40 Cortical Burr Sphere 4mm Prostep Mis Arthrodesis Burrs Drill Bit 1.8mm Sterile (D0118C2S) Surgibit® 3.2mm 3-Fluted SQC Drill Bit, 145mm Blank (10-3230145) STEP DRILL 1.8 X 12MM STERILE (D001812S) DRILL BIT 3.3MM CANN (D0133C2N) 1456-7800 Drill Step Drill 1.8 X 12mm (D001812N) STEP DRILL 1.8 X 22MM STERILE (D001822S) DRILL BIT 2.2MM STERILE (D0122C2S) Surgibit® 5mm 3-Fluted SQC Drill Bit, 230mm Blank (10-5045230) 7MM GUIDE WIRE DRILL TIP COCR 450MM (2004-0024) 2004-0022 2.7mm Guide Wire Drill Tip CoCr 300mm 58SC2008 Sculpting Burr Cylinder 2X8mm Prostep Mis Arthrodesis Burrs Flexible Drill, 3.2mm, SFP (282-1-11117-R1) Altivate Anatomic AG, Non-Cannulated Center Drill, Full Wedge (804-09-018) Drill Bit 1.8mm (D0118C2N) 2.7MM GUIDE WIRE THD TROCAR TIP COCR 450MM (2004-0025) Drill Bit 5.3mm Cann (D0153C2N) 2004-0023 2.7mm Guide Wire Thd Trocar Tip CoCr 300mm Step Drill 2.2 X 22mm (D002222N) Drill Bit 2.2mm (D0122C2N) 58SC3012 Sculpting Burr Cylinder 3X12mm Prostep Mis Arthrodesis Burrs 58CF4008 Cartilage Burr Flame 4X8mm Prostep Mis Arthrodesis Burrs 58CC2008 Cartilage Burr Cylinder 2x8mm Prostep Mis Arthrodesis Burrs 58CC4016 Cartilage Burr Cylinder 4X16mm Prostep Mis Arthrodesis Burrs 58CC3012 Cartilage Burr Cylinder 3X12mm Prostep Mis Arthrodesis Burrs Drill Bit, 3.2 x 45mm, Bayonet (803-15-009) 58SC4016 Sculpting Burr Cylinder 4x16mm Prostep Mis Arthrodesis Burrs Altivate Anatomic AG, Cannulated Center Drill, Half Wedge (804-09-017) Drill Bit, 3.2x35mm, Bayonet (803-15-008) 881-1-10022 (Crown Drill, SFP) DRILL, 2.5mm X 127mm (1395-1025) DRILL BIT, 4MM, CALIBRATED (804-03-049) Intertan Max 6mm Compression Screw Drill (Single Use) (81122701) 2.2 mm Over Drill Bit Arsenal 330-22-011 INTERTAN MAX 10.5MM LAG SCREW DRILL (SINGLE USE) (81122697) 3.5mm Drill Bit Arsenal 330-35-001 4.5 Spade Pilot Drill Two Step Hammer Toe Implant System 214-00-007 3.5mm Arsenal Screw Drill Bit Arsenal 340-35-001 2.2mm Arsenal Screw Drill Bit Arsenal 330-22-001 2.7mm Drill Bit Arsenal 330-27-001 3.4 Spade Pilot Drill Two Step Hammer Toe Implant System 214-00-006 2.4mm Thread Pilot Drill Two Step Hammer Toe 214-00-017 3.5 mm Over Drill Bit Arsenal 330-35-011 2.7mm Arsenal Screw Drill Bit Arsenal 340-27-001 3 Thread Pilot Drill Two Step Hammer Toe 214-00-013 INTERTAN MAX 7.6MM COMPRESSION SCREW STARTER DRILL (Single Use) (81122703) 4 Prox Drill Tiger Cannulated 213-40-002 Malleolus Implant Drill Bit 340-45-001 3.5mm Arsenal Drill Arsenal 330-35-013 INTERTAN MAX 6MM COMPRESSION SCREW DRILL (REUSABLE) (81122700)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)