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De Soutter Medical Osteodrive II and accessories - HSA Registration DE0509837

Access comprehensive regulatory information for De Soutter Medical Osteodrive II and accessories in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509837 and owned by De Soutter Medical Ltd. The device was registered on September 25, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0509837
De Soutter Medical Osteodrive II and accessories
HSA Registration Number: DE0509837
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Product Description

Osteodrive II is intended for use in combination with the PC-47x Power Console to efficiently drill, ream, bur or cut bone, metal and hard tissue. The equipment is also intended to drive wires and pins into bone.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0509837
Registration Date
September 25, 2024
Retention Due Date
September 24, 2025
Product Owner
Short Name
De Soutter Medical Ltd
Address
Halton Brook Business Park, Weston Road, Aston Clinton, Aylesbury, Buckinghamshire, HP22 5WF, UNITED KINGDOM
Registrant
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #06-17, SINGAPORE 159471
Importer
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #06-17, SINGAPORE 159471
Model Information
Model Name(s)
BAG SUPPORT MCI-280 OSTEODRIVE HANDPIECE - STRAIGHT CASE (35k) MCI-281 OSTEODRIVE HANDPIECE - STRAIGHT CASE HI-SPEED (65k) DCS-280 OSTEODRIVE SAGITTAL SAW HANDPIECE - S86 MCU-480 OSTEODRIVE HANDPIECE - PISTOL GRIP AV-221 CONTRA-ANGLE HEAD 20 1/2 SIZE WIRE STERI-CASE PC-471 POWER CONSOLE - ADVANCED PC-472 POWER CONSOLE - ADVANCED - WITH IRRIGATION 1/2 SIZE STERILE FILTERED STERI-CASE -299 x 278 x 155mm BLUE STD SIZE STERILE PTFE FILTERED STERI-CASE- 585 x 278 x 155mm FS-272 FOOT SWITCH - CORDED FOR HEKADRILL OU-480 OSCILLATING SAW HEAD BUR GUARD - METAL CUTTER - 3.18 x 60mm SI-280 SAGITTAL SAW HEAD - S86 SU-480 SAGITTAL SAW HEAD (S86) CU-480 RECIP SAW HEAD (S83) HU-480 HI-TORQUE REAMER HEAD DHS/DCS DRIVE SU-481 SAGITTAL SAW HEAD - ROTATING (S86) BI-281 ROTARY BUR HEAD - HEKA (65k rpm) HANDLE - 280 SERIES BUR GUARD - 2.38 x 100MM BUR GUARD - 2.38 x 70MM LEVER - 280 SERIES DI-280 DRILL HEAD - 4.0MM KEYED CHUCK DI-280 DRILL HEAD - A.O. SYNTHES DI-280 OFFSET DRILL HEAD - A.O. SYNTHES DI-280 OFFSET DRILL HEAD - 4.0MM KEYED CHUCK QI-280 MICRO DRILL HEAD - ISO 1797 TYPE 1 BI-280 ROTARY BUR HEAD - 2.38mm (35k rpm) BI-287 ROTARY BUR HEAD - 2.38mm (9k rpm) NI-280 SAGITTAL SAW HEAD - S88 CI-280 RECIPROCATING SAW HEAD - S83 OI-280 OSCILLATING SAW HEAD - S86 OI-281 OSCILLATING SAW HEAD - S86-9xxx WI-280 ANGLED WIRE DRIVER HEAD WI-281 IN-LINE WIRE DRIVER HEAD DU-480 DRILL HEAD - 4.0MM KEYED CHUCK DU-480 DRILL HEAD - 7.4MM KEYED CHUCK DU-480 DRILL HEAD - 3.2MM KEYLESS CHUCK DU-480 DRILL HEAD - 7.4MM KEYLESS CHUCK DU-480 DRILL HEAD - A.O. SYNTHES DU-480 DRILL HEAD - HUDSON/ZIMMER COMBI DU-480 DRILL HEAD - DHS/DCS DU-480 DRILL HEAD - AESCULAP QU-480 MICRO DRILL HEAD - ISO 1797 TYPE 1 RU-480 REAMER HEAD - 7.4MM KEYED CHUCK RU-480 REAMER HEAD - A.O. SYNTHES RU-480 REAMER HEAD - HUDSON/ZIMMER COMBI RU-480 REAMER HEAD - HUDSON RU-480 REAMER HEAD - ZIMMER RU-480 REAMER HEAD - DHS/DCS RU-481 NON REVERSIBLE REAMER HEAD - A.O. SYNTHES BU-480 BUR HEAD - 2.38mm NU-480 SAGITTAL SAW HEAD - S88 NU-481 SAGITTAL SAW HEAD - S88 XL NU-482 SAGITTAL SAW HEAD - HIGH SPEED - S88 WU-480 WIRE DRIVER HEAD 0.6 - 1.8MM WU-481 WIRE/PIN DRIVER HEAD 0.7 - 4.0MM PU-480 PIN DRIVER HEAD 1.8 - 3.2MM STD SIZE STERI-TRAY - 1 x MCU, 1 x MCI & 1 x DCS STD SIZE STERI-CASE & TRAY - 1 x MCU, 1 x MCI & 1 x DCS 1/2 SIZE STERI-TRAY - 1 x MCI & 1 x DCS 1/2 SIZE STERI-CASE & TRAY - 1 x MCI & 1 x DCS BUR GUARD - STANDARD BUR GUARD - LONG BUR GUARD - X LONG PTFE FILTER CASSETTE AV-220 ANGLE HEAD 20 - STD AV-220 ANGLE HEAD 20 - LONG IRRIGATION KIT - GENERAL PURPOSE - MCI IRRIGATION KIT - METAL CUTTING - MCI IRRIGATION KIT - BURS - MCI IRRIGATION NOZZLE - GENERAL PURPOSE
Model Identifier(s)
12940 1294664 1294774 1294884 1295004 14940 19000 19080 19090 19370 19810 19910 20300 20460 20550 20570 20580 20610 20620 20630 20650 20660 20670 20680 20690 20700 20710 20720 20730 20740 20750 20760 20770 20780 20790 20800 20810 20820 20830 20840 20850 20860 20870 20880 20890 20900 20910 20920 20930 20940 20950 20960 20970 20980 20990 21000 21010 21050 21060 21070 21080 21090 21100 21110 21120 21130 21140 671073 9770 9780 T20-100 T20-101 T20-102 T20-170