Instrumed International, Inc.: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.

1) Instrumed Item No.: 250-08800; Adler Instrument Company Catalog Code: 70-0300; Lot Number: 070113; 2) Instrumed Item No.: 250-08860 ; Adler Instrument Company Catalog Code: 70-0319; Lot Number: 030312, 070411; 3) Instrumed Item No.: 250-08930; Adler Instrument Company Catalog Code: 70-0318; Lot Number: 010113, 020113, 030112, 050412, 060413, 070512, 090213, 100113, 100411; 4) Instrumed Item No.: 250-08960 ; Adler Instrument Company Catalog Code: AD98-1008; Lot Number: 090310; 5) Instrumed Item No.: 250-09010 ; Adler Instrument Company Catalog Code: 70-0317; Lot Number: 100211

1) Instrumed Item No.: 250-08930; Ambler Surgical Corporation Catalog Code: J647-6; Lot Number: 060412;

1) Instrumed Item No.: 250-08680; Boss Instruments Catalog Code: 35-8015; Lot Number: 030411, 100110, 110210; 2) Instrumed Item No.: 250-08700; Boss Instruments Catalog Code: 35-8016; Lot Number: 030111; 3) Instrumed Item No.: 250-08700; Boss Instruments Catalog Code: 35-8016; Lot Number: 30111; 4) Instrumed Item No.: 250-08760; Boss Instruments Catalog Code: 35-8020; Lot Number: 020411, 070111, 100412, 110412; 5) Instrumed Item No.: 250-08770; Boss Instruments Catalog Code: 35-8020L; Lot Number: 020112, 110211, 120310; 6) Instrumed Item No.: 250-08800; Boss Instruments Catalog Code: 35-8025; Lot Number: 060110, 100112; 7) Instrumed Item No.: 250-08820; Boss Instruments Catalog Code: 35-8026 ; Lot Number: 032811; 8) Instrumed Item No.: 250-08860; Boss Instruments Catalog Code: 35-8030; Lot Number: 050413, 070412, 110510, 090110; 9) Instrumed Item No.: 250-08880; Boss Instruments Catalog Code: 35-8030L; Lot Number: 090110; 10) Instrumed Item No.: 250-08890; Boss Instruments Catalog Code: 35-8035; Lot Number: 100213; 11) Instrumed Item No.: 250-08930; Boss Instruments Catalog Code: 35-8040; Lot Number: 010211, 020213, 020811, 021711, 040212, 040311, 080212, 100310, 110113, 120413; 12) Instrumed Item No.: 250-08960; Boss Instruments Catalog Code: 35-8040L; Lot Number: 030413, 040412, 040513, 120113; 13) Instrumed Item No.: 250-08990; Boss Instruments Catalog Code: 35-8042; Lot Number: 050312; 14) Instrumed Item No.: 250-09000; Boss Instruments Catalog Code: 35-8042L; Lot Number: 100406; 15) Instrumed Item No.: 250-09010; Boss Instruments Catalog Code: 35-8045; Lot Number: 010311, 020311, 090312, 100212, 120112, 120213

1) Instrumed Item No.: 250-08570; CareFusion Catalog Code: VM46-9112-1; Lot Number: 010111; 2) Instrumed Item No.: 250-08600; CareFusion Catalog Code: LA8523 ; Lot Number: 070211, 070213, 090412; 3) Instrumed Item No.: 250-08610; CareFusion Catalog Code: LA8523-45; Lot Number: 042011, 062209; 4) Instrumed Item No.: 250-08620; CareFusion Catalog Code: LA8515; Lot Number: 030511, 040310, 080111; 5) Instrumed Item No.: 250-08630; CareFusion Catalog Code: LA8515-45; Lot Number: 050212; 6) Instrumed Item No.: 250-08660; CareFusion Catalog Code: LA8514; Lot Number: 040110; 7) Instrumed Item No.: 250-08670; CareFusion Catalog Code: LA8514-45; Lot Number: 120410; 8) Instrumed Item No.: 250-08680; CareFusion Catalog Code: LA8526; Lot Number: 010313, 060311, 060312; 9) Instrumed Item No.: 250-08690; CareFusion Catalog Code: LA8526-45; Lot Number: 030314, 100410, 120110, 120312; 10) Instrumed Item No.: 250-08700; CareFusion Catalog Code: LA8518; Lot Number: 060111, 070110, 080211; 11) Instrumed Item No.: 250-08710; CareFusion Catalog Code: LA8518-45; Lot Number: 010114, 040113, 040313, 060410; 12) Instrumed Item No.: 250-08730; CareFusion Catalog Code: LA8520-45; Lot Number: 010213; 13) Instrumed Item No.: 250-08740; CareFusion Catalog Code: LA8519; Lot Number: 060108, 080310; 14) Instrumed Item No.: 250-08760; CareFusion Catalog Code: LA8521; Lot Number: 020212, 060113, 060213, 100513, 121410; 15) Instrumed Item No.: 250-08770; CareFusion Catalog Code: LA8521-45; Lot Number: 100210; 16) Instrumed Item No.: 250-08780; CareFusion Catalog Code: LA8513; Lot Number: 010110, 050313, 070112, 122110; 17) Instrumed Item No.: 250-08790; CareFusion Catalog Code: LA8513-45; Lot Number: 090411, 100309, 100312; 18) Instrumed Item No.: 250-08800; CareFusion Catalog Code: LA8525; Lot Number: 040114, 090410, 110310, 120111; 19) Instrumed Item No.: 250-08810; CareFusion Catalog Code: LA8525-45; Lot Number: 050308, 060310; 20) Instrumed Item No.: 250-08820; CareFusion Catalog Code: LA8517; Lot Number: 110410, 120212; 21) Instrumed Item No.: 250-08860; CareFusion Catalog Code: LA8507; Lot Number: 011111, 020111, 030210, 041411, 060112, 060313, 070312, 070712, 100413, 100512, 110112, 110313, 110413; 22) Instrumed Item No.: 250-08880; CareFusion Catalog Code: LA8507-45; Lot Number: 061011, 070313, 070513; 23) Instrumed Item No.: 250-08890; CareFusion Catalog Code: LA8506; Lot Number: 020211, 020410; 24) Instrumed Item No.: 250-08900; CareFusion Catalog Code: LA8506-45; Lot Number: 050407; 25) Instrumed Item No.: 250-08930; CareFusion Catalog Code: LA8505; Lot Number: 010314, 010513, 010611, 030113, 032211, 040112, 090313, 100111, 120710; 26) Instrumed Item No.: 250-08960; CareFusion Catalog Code: LA8505-45; Lot Number: 30313, 090113, 110110, 120211; 27) Instrumed Item No.: 250-08970; CareFusion Catalog Code: LA8504; Lot Number: 050110, 080510; 28) Instrumed Item No.: 250-08980; CareFusion Catalog Code: LA8504-45; Lot Number: 050311; 29) Instrumed Item No.: 250-08990; CareFusion Catalog Code: LA8503; Lot Number: 020414, 042310, 110411; 30) Instrumed Item No.: 250-09000; CareFusion Catalog Code: LA8503-45; Lot Number: 020512; 31) Instrumed Item No.: 250-09010; CareFusion Catalog Code: LA8509; Lot Number: 020413, 021511, 030211, 030212, 030G12, 03101816-; 32) Instrumed Item No.: 250-09030; CareFusion Catalog Code: LA8509-45; Lot Number: 070212; 33) Instrumed Item No.: 250-09040; CareFusion Catalog Code: LA8510; Lot Number: 040411; 34) Instrumed Item No.: 250-09070; CareFusion Catalog Code: LA8508-45; Lot Number: 050410; 35) Instrumed Item No.: 250-09100; CareFusion Catalog Code: VM46-9183; Lot Number: 060411; 36) Instrumed Item No.: 250-09120; CareFusion Catalog Code: VM46-9185; Lot Number: 090308

1) Instrumed Item No.: 250-08930; Pilling Weck Inc. / Teleflex Medical Catalog Code: 728163; Lot Number: 66745

1) Instrumed Item No.: 250-08930; Specialty Care Catalog Code: 30-92221; Lot Number: 040413

1) Instrumed Item No.: 250-08860; Symmetry Surgical Inc. Catalog Code: 90-9525; Lot Number: 030214; 2) Instrumed Item No.: 250-08930; Symmetry Surgical Inc. Catalog Code: 90-9522; Lot Number: 070511; 3) Instrumed Item No.: 250-08990; Symmetry Surgical Inc. Catalog Code: 90-9526; Lot Number: 031511; 4) Instrumed Item No.: 250-09010; Symmetry Surgical Inc. Catalog Code: 90-9523; Lot Number: 080112

1) Instrumed Item No.: 250-09010; Phoenix Instruments Catalog Code: 190-9523; Lot Number: 070411; 2) Instrumed Item No.: 250-09040; Phoenix Instruments Catalog Code: 190-9527; Lot Numbers: 010211, 040411

1) Instrumed Item No.: 250-08930; Surgical Direct Catalog Code: SD175200.100; Lot Number: 070512; 2) Instrumed Item No.: 250-08700; Surgical Direct Catalog Code: SD11451.140; Lot Number: 080211; 3) Instrumed Item No.: 250-08930; Surgical Direct Catalog Code: SD175200.100; Lot Numbers: 030112, 080212, 010113, 020113; 4) Instrumed Item No.: 250-08960; Surgical Direct Catalog Code: SD17520045.100; Lot Number: 070412; 5) Instrumed Item No.: 250-089360; Surgical Direct Catalog Code: SD175200.100; Lot Number: 030413

1) Instrumed Item No.: 250-08660; Surgimed - MLB Catalog Code: 91-112; Lot Numbers: 040110, 100112