Nchi: Singapoo
Lugha: Kiingereza
Chanzo: HSA (Health Sciences Authority)
HUMEDICAL (S) PTE. LTD.
Class C medical device
OsteoMed L.P
Neurology
Indicated for fixation secondary to trauma or reconstruction of craniofacial and maxillofacial skeleton. The implantable screws, plates, meshes, and drills are intended for single use only.
Device System Info:[System or Procedure Pack], The system is comprised of screws and plates used for fixation of craniofacial and maxillofacial skeleton, fractures, and reconstructions.; Models: 1.2mm x 3mm AUTO-DRIVE® Screw - 2111203, 1.2mm x 4mm AUTO-DRIVE® Screw - 2111204, 1.2mm x 5mm AUTO-DRIVE® Screw - 2111205, 1.5mm x 3mm Safety Screw - 2041503, 5 Medium, 2 Hole, Straight Plate - 2120130, Long, 2 Hole, Straight Plate - 2120132, Square Plate - 2120134, Extended "X" Plate - 2120136, Extended Double "Y" Plate - 2120138, 18 Hole Straight Plate - 2120034, 12 Hole Curved Plate - 2120036, 5 Hole Straight Plate - 2120038, 2 x 4 Hole Quad Plate - 2120040, Small Bur Hole Plate - 2120140, Large Bur Hole Plate - 2120142, X-Large Bur Hole Plate - 2120144, 40 x 40mm OsteoForm Mesh, 1.2mm - 2120146, 90 x 90mm OsteoForm Mesh, 1.2mm - 2120148, Micro Mesh, 74mm x 50mm - 2120150, TaperLock Screwdriver Body - 2200019, 1.2mm Screwdriver Shaft, Manual - 2200022, Small Grasping Forceps - 2200027, Plate Cutter - 2200028, Plate Bending Forceps - 2200049, 1.2mm Screwdriver Shaft, Long, Manual - 2200081, 1.2mm AUTO-DRIVE® Screw VISIDISK™ (YELLOW) - 2200085, 1.6mm Screwdriver Shaft, Long, Manual - 220-0086, 1.0mm Pilot Drill, 6mm Stop, J-Latch - 220-0089, .9mm Pilot Drill, 3mm stop, J-Latch - 2200318, .9mm Pilot Drill, 4mm stop, J-Latch - 2200319, .9mm Pilot Drill, 5mm stop, J-Latch - 2200320, FAST-FLAP Delivery System Organizer Tray - 2220200, 1.2mm Fast Flap Plate Organizer (II) - 2220201, Mesh Fast-Flap Plate Organizer (II) - 2220204, OsteoDriver™ Disposable AutoDriver™ - 4500600, 1.2mm Driver Stem, OsteoDriver™ - 4500618, 1.6mm x 4mm AUTO-DRIVE® Screw - 2111604, 1.6mm x 5mm AUTO-DRIVE® Screw - 2111605, 1.6mm x 6mm AUTO-DRIVE® Screw - 2111606, 1.9mm x 4mm Safety Screw - 2081904, 9mm Square Plate - 2180020, Short 2 Holes Straight Plate - 2180022, Medium 2 Hole Straight Plate - 2180024, Long 2 Hole Straight Plate - 2180026, Double "Y" Plate - 2180028, 5 Hole Straight Plate - 2180030, Small Bur Hole Plate - 2180032, Small Bur Hole Plate, Long Arm - 2180033, Large Bur Hole Plate - 2180034, 10 Hole Straight Plate - 2180038, 25mm Gap Plate - 2180042, 35mm Gap Plate - 2180044, 45mm Gap Plate - 2180046, 21 x 33mm Sub-Temporal Plate - 2180048, 30 x 48mm Sub-Temporal Plate - 2180050, 2 x 3 Hole Quad Plate - 2180059, 2 x 4 Hole Quad Plate - 2180060, Bur Hole Shunt Plate - 2180061, X-Large Bur Hole Plate - 2180062, 9mm Square Plate, Rigid - 2180080, Medium 2 Hole Straight Plate, Rigid - 2180081, Long 2 Hole Straight Plate, Rigid - 2180082, 36mm x 50mm Mesh Plate - 2180036, 74mm x 50mm Mesh Plate - 2180039, 111mm x 191mm Mesh Plate - 2180040, 74mm x 50mm Mesh Plate, Rigid - 2180052, 1.6mm Screwdriver Shaft, Manual - 2200061, 1.6mm Auto-Drive™ Screw Visidisk - 2200076, Screwdriver Body, MRI Compatible - 222-0100, 1.6mm Titanium Screwdriver Shaft (use only w/ 222-0100) - 222-0106, 1.6mm Fast-Flap Plate Organizer (II) - 2220202, Skull Base Fast-Flap Plate Organizer (II) - 2220203, 1.1mm Pilot Drill, 4mm Stop, J-Latch - 2220004, 1.1mm Pilot Drill, 4mm Stop, Manual - 2220005, 1.1mm Pilot Drill, 6mm Stop, J-Latch - 2220006, 1.1mm Pilot Drill, 4mm stop, Midas Rex - 2220300, 1.1mm Pilot Drill, 6mm stop, Midas Rex - 2220301, 1.1mm Pilot Drill, 4mm stop, Osteopower - 2220304, 1.1mm Pilot Drill, 6mm stop, Osteopower - 2220306, Driver Stem, 1.6, OsteoDriver™ Disposable AutoDriver - 4500601, Driver Stem, 1.6, Extended OsteoDriver™ Disposable AutoDriver - 4500619, 150 x 300mm Mesh Plate - 2180041, 125mm x 180mm Mesh Plate, Rigid, 1.6mm - 2180053, 1.6mm, Low Profile, 9mm Square Plate - 2180090, 1.6mm Low Profile Short2 Hole Straight Plate - 2180091, 1.6mm Low Profile Medium 2 Hole Straight Plate - 2180092, 1.6mm Low Profile Long 2 Hole straight Plate - 2180093, 1.6mm Low Profile, Small Bur Hole Plate - 2180094, 1.6mm Low Profile, Large Bur Hole Plate - 2180095, 1.6mm Low Profile, X-Large Bur Hole Plate - 2180096, 40 x 40mm Malleable OsteoForm Mesh - 2182001, 40mm x 40mm Rigid OsteoForm Mesh - 2182002, 90mm x 90mm alleable OsteoForm Mesh - 2182003, 90mm x 90mm Rigid OsteoForm Mesh - 2182004, 165 x 95mm Pre-Formed OsteoForm Mesh - 2182005, 90 x 90mm Pre-Formed OsteoForm Mesh - 2182006, 165 x 95mm Rigid OsteoForm Mesh - 2182007, 165 x 95mm Pre-Formed OsteoForm Mesh, Extra-Rigid - 2182008, 165 x 95mm OsteoForm Mesh, Extra Rigid - 2182014, 1.6mm x 3mm Screw - 2081603, 1.6mm x 4mm Screw - 2081604, 1.6mm x 5mm Screw - 2081605, 1.6mm x 6mm Screw - 2081606
2008-07-03