HSA · registration DE0509837

De Soutter Medical Osteodrive II and accessories

Name: De Soutter Medical Osteodrive II and accessories — HSA DE0509837
Creator: De Soutter Medical Ltd
Keywords: De Soutter Medical Osteodrive II and accessories, De Soutter Medical Osteodrive II and accessories, DE0509837, Orthopaedics, HSA

SingaporeOrthopaedicsClass BDe Soutter Medical Ltd

Verified

Official record identity

Registration number: DE0509837
Model name: 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: 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
Registration date: September 25, 2024

Classification

Risk class: Class B
Published category: Orthopaedics

Published parties

Product owner: De Soutter Medical Ltd
Registrant / registration holder: HUMEDICAL (S) PTE. LTD.

Official 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.

Additional source fields

Product owner address: Halton Brook Business Park, Weston Road, Aston Clinton, Aylesbury, Buckinghamshire, HP22 5WF, United Kingdom
Registrant address: 3791 JALAN BUKIT MERAH, #06-17, E-CENTRE @ REDHILL, Singapore 159471

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.