TAKAYAMA INSTRUMENT INC.

iON-SU Suture Passers ST-T1 Sterilization Tray Single Size (2.8x8.7x1.3in) ST-L1 Sterilization Tray Large Hospital Size (10x17x1.5in) ST-S1 Sterilization Tray Small (8.7x10x1.5in) KT-702 Kamiyama-Tsuboi Micro Rongeur K-Bayonet, 200mm (90mm W.L.), Slightly Curved Tip MT-15-C30 Micro-Rongeur, Double link, Curved 30 deg neck, 1.5mm Blades width MT-25-C30 Micro-Rongeur, Double link, Curved 30 deg neck, 2.5mm Blades width MT-15-S Micro-Rongeur, Double link, Straight neck, 1.5mm Blades width KT-701 Kamiyama-Tsuboi Micro Rongeur K-Bayonet, 200mm (90mm W.L.), Straight Tip MT-15-C15 Micro-Rongeur, Double link, Curved 15 deg neck, 1.5mm Blades width MT-25-C15 Micro-Rongeur, Double link, Curved 15 deg neck, 2.5mm Blades width TK-20BR-AS Micro-Rongeur, Straight handle, 205mm, One side thinner blade MT-25-S Micro-Rongeur, Double link, Straight neck, 2.5mm Blades width K-700 Kamiyama Micro Rongeur K-Bayonet, 180mm (70mm W.L.), Curved Tip TK-20BR Micro-Rongeur, Straight handle, 205mm SB-70N-60 SuperBypass Micro Needle Holder Bayonet, 175mm (70mm W.L.), 60degree SBTi-90N-30 SuperBypass Titan Micro Needle Holder Bayonet, 195mm (90mm W.L.), 30degree, Titanium SB-110N-45 SuperBypass Micro Needle Holder Bayonet, 215mm (110mm W.L.), 45degree SBTi-110N-45-S SuperBypass Titan Micro Needle Holder Bayonet, 215mm (110mm W.L.), 45degree, Small Tip, Titanium SBTi-70N-60-S SuperBypass Titan Micro Needle Holder Bayonet, 175mm (70mm W.L.), 60degree, Small Tip, Titanium KTP-230 Kamiyama Microdissector 185mm, 2x3mm, 360degree cutting edge SB-90N-60 SuperBypass Micro Needle Holder Bayonet, 195mm (90mm W.L.), 60degree SBTi-110N-30 SuperBypass Titan Micro Needle Holder Bayonet, 215mm (110mm W.L.), 30degree, Titanium S-16YM-N1 YUKIMURA Micro Needle Holder Straight, 160mm SBTi-90N-60-S SuperBypass Titan Micro Needle Holder Bayonet, 195mm (90mm W.L.), 60degree, Small Tip, Titanium K-810 Kamiyama Micro Needle Holder K-Bayonet, 200mm (90mm W.L.), 45degree, 3.5mm Tip SB-16NC-MZ-L1 SuperBypass Micro Needle Holder Scissors Straight, 160mm, Large-size nose, Mario Zuccarello Special SBTi-90N-60 SuperBypass Titan Micro Needle Holder Bayonet, 195mm (90mm W.L.), 60degree, Titanium K-805 Kamiyama Micro Needle Holder K-Bayonet, 180mm (70mm W.L.), 45degree, 3.5mm Tip K-808 Kamiyama Micro Needle Holder K-Bayonet, 200mm (90mm W.L.), Straight Tip SBTi-90N-45 SuperBypass Titan Micro Needle Holder Bayonet, 195mm (90mm W.L.), 45degree, Titanium SB-110N-30 SuperBypass Micro Needle Holder Bayonet, 215mm (110mm W.L.), 30degree SBTi-110N-45 SuperBypass Titan Micro Needle Holder Bayonet, 215mm (110mm W.L.), 45degree, Titanium SBTi-70N-60 SuperBypass Titan Micro Needle Holder Bayonet, 175mm (70mm W.L.), 60degree, Titanium KTP-1520 Kamiyama Microdissector 185mm, 1.5x2mm, 360degree cutting edge SB-90N-45 SuperBypass Micro Needle Holder Bayonet, 195mm (90mm W.L.), 45degree IK-120 Kamiyama Microdissector 185mm, 1x2mm, 180degree cutting edge SB-16NC-MZ-S1 SuperBypass Micro Needle Holder Scissors Straight, 160mm, Small-size nose, Mario Zuccarello Special SB-90N-30 SuperBypass Micro Needle Holder Bayonet, 195mm (90mm W.L.), 30degree IK-1520 Kamiyama Microdissector 185mm, 1.5x2mm, 180degree cutting edge SBTi-110N-30-S SuperBypass Titan Micro Needle Holder Bayonet, 215mm (110mm W.L.), 30degree, Small Tip, Titanium KTP-340 Kamiyama Microdissector 185mm, 3x4mm, 360degree cutting edge SB-16NC SuperBypass Micro Needle Holder Straight, 160mm CEA IK-230 Kamiyama Microdissector 185mm, 2x3mm, 180degree cutting edge SB-110N-60 SuperBypass Micro Needle Holder Bayonet, 215mm (110mm W.L.), 60degree SB-70N-30 SuperBypass Micro Needle Holder Bayonet, 175mm (70mm W.L.), 30degree KTP-120 Kamiyama Microdissector 185mm, 1x2mm, 360degree cutting edge IK-340 Kamiyama Microdissector 185mm, 3x4mm, 180degree cutting edge SB-70N-45 SuperBypass Micro Needle Holder Bayonet, 175mm (70mm W.L.), 45degree K-809 Kamiyama Micro Needle Holder K-Bayonet, 200mm (90mm W.L.), Slightly Curved Tip SBTi-90N-45-S SuperBypass Titan Micro Needle Holder Bayonet, 195mm (90mm W.L.), 45degree, Small Tip, Titanium K-8250 Kamiyama Micro Needle Holder K-Bayonet, 180mm (70mm W.L.), 45degree, 1.5mm Tip K-8210 Kamiyama Micro Needle Holder K-Bayonet, 200mm (90mm W.L.), 45degree, 1.5mm Tip SBTi-90N-30-S SuperBypass Titan Micro Needle Holder Bayonet, 195mm (90mm W.L.), 30degree, Small Tip, Titanium K-500 Kamiyama Micro Dilator Straight, 185mm, 45degree Tip K-814 Kamiyama Micro Needle Holder Straight, 160mm, Slightly Curved Tip SBTi-70N-30 SuperBypass Titan Micro Needle Holder Bayonet, 175mm (70mm W.L.), 30degree, Titanium K-815 Kamiyama Micro Needle Holder Straight, 160mm, 45degree Tip SBTi-70N-45 SuperBypass Titan Micro Needle Holder Bayonet, 175mm (70mm W.L.), 45degree, Titanium K-804 Kamiyama Micro Needle Holder K-Bayonet, 180mm (70mm W.L.), Slightly Curved Tip SBTi-110N-60-S SuperBypass Titan Micro Needle Holder Bayonet, 215mm (110mm W.L.), 60degree, Small Tip, Titanium SBTi-16NC SuperBypass Titan Micro Needle Holder Straight, 160mm, Titanium K-803 Kamiyama Micro Needle Holder K-Bayonet, 180mm (70mm W.L.), Straight Tip SBTi-110N-60 SuperBypass Titan Micro Needle Holder Bayonet, 215mm (110mm W.L.), 60degree, Titanium Product: OJG - Neurological tray SSTi-SET-MY22 SuperBypass Suction-Irrigation MiNi system starter kit 1 (1 HP, 4 Tips, 2 Stylets ,2 Stylet Insert Cover SSTi-SET1 SuperBypass Suction-Irrigation system starter kit 1 (1 HP, 4 Tips, 2 Stylets, 1 L-Wrench) SSTi-01 SuperBypass Suction-Irrigation Hand-Piece SSTi-SET-MY22L SuperBypass Suction-Irrigation MiNi system starter kit 1 For Left-Handed Psn (1 HP, 4 Tips, 2 Stylet SSTi-MY22L SuperBypass Suction-Irrigation MiNi Hand-Piece For Left-Handed Psn SSTi-MY22 SuperBypass Suction-Irrigation MiNi Hand-Piece SSTi-SET1L SuperBypass Suction-Irrigation system starter kit 1 For Left-Handed Person (1HP, 4Tips, 2Stylet, 1L-Wnch) SSTi-01L SuperBypass Suction-Irrigation Hand-Piece For Left-Handed Person SSTi-032 Stylet Insert Cover (2pcs) SSTi-MY22-029 Cleaning Stylet for MY22 Hand-Piece SB-1207-MTL SuperBypass Microforceps Straight, 120mm, 7mm platform, FINE Michael T. Lawton Special SBTi-1207 SuperBypass Titan Microforceps Straight, 120mm, 7mm platform, Titanium K-806 Kamiyama Microforceps K-Bayonet, 200mm (90mm W.L.), Straight Tip K-8270 Kamiyama Microforceps K-Bayonet, 200mm (90mm W.L.), 45degree, 1.5mm Tip K-802 Kamiyama Microforceps K-Bayonet, 180mm (70mm W.L.), 45degree, 3.5mm Tip KP-P01 Kamiyama Microforceps Premium K-Bayonet, 200mm (90mm W.L.), Straight Tip SB-110FC SuperBypass Microforceps Bayonet, 215mm (110mm W.L.), Curved Tip SB-1607-MTL SuperBypass Microforceps Straight, 160mm, 7mm platform, FINE Michael T. Lawton Special SBTi-1610C SuperBypass Titan Microforceps Straight, 160mm, 10mm platform, Curved Tip, Titanium SBTi-110FS SuperBypass Titan Microforceps Bayonet, 215mm (110mm W.L.), Straight Tip, Titanium SB-1610-MTL SuperBypass Microforceps Straight, 160mm, 10mm platform, FINE Michael T. Lawton Special SBTi-70FC SuperBypass Titan Microforceps Bayonet, 175mm (70mm W.L.), Curved Tip, Titanium KP-P03 Kamiyama Microforceps Premium Straight, 160mm SBTi-90FS SuperBypass Titan Microforceps Bayonet, 195mm (90mm W.L.), Straight Tip, Titanium KP-P01JFM Kamiyama Microforceps Premium K-Bayonet, 220mm (110mm W.L.), Straight Tip, Juan C. Fernandez-Miranda Special SB-70FC SuperBypass Microforceps Bayonet, 175mm (70mm W.L.), Curved Tip H-102 Kamiyama Microforceps Hida Straight, 180mm, Straight Tip K-811 Kamiyama Microforceps Straight, 160mm, Straight Tip KP-P04 Kamiyama Microforceps Straight, 160mm, 45degree Tip SB-1210-MTL SuperBypass Microforceps Straight, 120mm, 10mm platform, FINE Michael T. Lawton Special SB-90FS SuperBypass Microforceps Bayonet, 195mm (90mm W.L.), Straight Tip SBTi-1607 SuperBypass Titan Microforceps Straight, 160mm, 7mm platform, Titanium SB-1210 SuperBypass Microforceps Straight, 120mm, 10mm platform SB-90FC SuperBypass Microforceps Bayonet, 195mm (90mm W.L.), Curved Tip SBTi-1210 SuperBypass Titan Microforceps Straight, 120mm, 10mm platform, Titanium SB-1607 SuperBypass Microforceps Straight, 160mm, 7mm platform SBTi-1610 SuperBypass Titan Microforceps Straight, 160mm, 10mm platform, Titanium SB-70FS SuperBypass Microforceps Bayonet, 175mm (70mm W.L.), Straight Tip SB-110FS SuperBypass Microforceps Bayonet, 215mm (110mm W.L.), Straight Tip SBTi-110FC SuperBypass Titan Microforceps Bayonet, 215mm (110mm W.L.), Curved Tip, Titanium K-812 Kamiyama Microforceps Straight, 160mm, 45degree Tip SBTi-70FS SuperBypass Titan Microforceps Bayonet, 175mm (70mm W.L.), Straight Tip, Titanium SB-1207 SuperBypass Microforceps Straight, 120mm, 7mm platform KP-P02 Kamiyama Microforceps Premium K-Bayonet, 200mm (90mm W.L.), 45degree, 1.5mm Tip K-801 Kamiyama Microforceps K-Bayonet, 180mm (70mm W.L.), Straight Tip K-807 Kamiyama Microforceps K-Bayonet, 200mm (90mm W.L.), 45degree, 3.5mm Tip SBTi-90FC-S SuperBypass Titan Microforceps Bayonet, 195mm (90mm W.L.), Small Curved Tip, Titanium SB-1610 SuperBypass Microforceps Straight, 160mm, 10mm platform K-8220 Kamiyama Microforceps K-Bayonet, 180mm (70mm W.L.), 45degree, 1.5mm Tip SBTi-90FC SuperBypass Titan Microforceps Bayonet, 195mm (90mm W.L.), Curved Tip, Titanium KP-S02-18 Kamiyama Microscissors Premium Straight, 180mm, Mini Blade K-110-2 Kamiyama Microscissors Bayonet, 195mm, Angled Shaft, Left-Handed K-103 Kamiyama Microscissors Straight, 160mm K-1030-18 Kamiyama Microscissors [MURAMASA] Straight, 180mm K-102-2 Kamiyama Microscissors Bayonet, 160mm, Left-Handed K-2030-18 Kamiyama Microscissors Straight, 180mm, Serrated Mini Blade K-1030 Kamiyama Microscissors [MURAMASA] Straight, 160mm K-3030 Kamiyama Microscissors Straight, 160mm, Serrated Blade K-2010 Kamiyama Microscissors K-Bayonet, 200mm, Serrated Mini Blade, Right-Handed K-110-1 Kamiyama Microscissors Bayonet, 195mm, Angled Shaft, Right-Handed KP-203-12MKB Kamiyama Microscissors Premium Straight, 120mm, Mini Blade, Mustafa K. Baskaya Special KP-S01 Kamiyama Microscissors Premium Straight, 160mm K-101-2 Kamiyama Microscissors Bayonet, 195mm, Left-Handed K-203-18 Kamiyama Microscissors Straight, 180mm, Mini Blade K-101-1 Kamiyama Microscissors Bayonet, 195mm, Right-Handed K-203 Kamiyama Microscissors Straight, 160mm, Mini Blade K-102-1 Kamiyama Microscissors Bayonet, 160mm, Right-Handed K-2030 Kamiyama Microscissors Straight, 160mm, Serrated Mini Blade KP-S01-18 (KP-S01-S) Kamiyama Microscissors Premium Straight, 180mm K-104 Kamiyama Microscissors Straight, 120mm K-103-18 Kamiyama Microscissors Straight, 180mm K-3030-18 Kamiyama Microscissors Straight, 180mm, Serrated Blade KP-S01KMS Kamiyama Microscissors Premium Straight, 180mm, Left-Handed Kiko-Mura Special KP-104MKB Kamiyama Microscissors Premium Straight, 120mm, Mustafa K. Baskaya Special KP-S01MTL Kamiyama Microscissors Premium Straight, 160mm, Left-Handed Michael T. Lawton Special K-111-2 Kamiyama Microscissors Bayonet, 195mm, Higher Curvature Blades, Left-Handed K-3010 Kamiyama Microscissors K-Bayonet, 200mm, Serrated Blade, Right-Handed K-111-1 Kamiyama Microscissors Bayonet, 195mm, Higher Curvature Blades, Right-Handed

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device