sonic

Lot numbers: L0117006, L0117007, L0217001, L0217002, L0217004, L0217006

Radiology Devices

2

No

The products were distributed to the following US states: CA, FL, GA, IA, IL, OH, TN, and VA. The products were distributed to the following foreign countries: Canada, United Kingdom, and Malta.

Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case

Serial numbers between 0100 and 1219 (inclusive)

General and Plastic Surgery Devices

Unclassified

No

1 distributor in Tucson, AZ, for further distribution to end users (physicians and medical facilities) nationwide & Puerto Rico, and in the following countries: Canada, Mexico, Australia, Switzerland, Israel, Saudi Arabia, Cyprus, Greece, Turkey, Germany, Dominican Republic, Sweden, Netherlands, China, Taiwan ROC, and S. Korea.

LySonix 2000 Ultrasonic Surgical Systems, MODEL NO. LY-2000. --- Old labeling: MANUFACTURED BY: MISONIX, INC. EXCLUSIVELY FOR SALE BY MENTOR CORPORATION UNDER EXCLUSIVE LICENSE FROM SONIQUE SURGICAL, INC. MISONIX, INC. 1938 NEW HIGHWAY, FARMINGDALE, NY 11735. || Device was manufactured from September 1996 to present.

Serial Numbers: NBF1001601IE NBA1000501IE NBA1100901IE  NBA1101001IE NBA1102701IE  NBA1102801IE NBC1001501IE NBC1002001IE NBC1002301IE NBC1002901IE NBD1000101IE NBE1001301IE NBF1000701IE NBF1001101IE  NBG1001001IE NBG1001201IE NBJ1002401IE NBL0901901IE NBL0902101IE NBL0902501IE NCE1001901IE NCF1002201IE NCG1000201IE NCG1001401IE NCG1001501IE NXT1001 NXT1002 NXT1003 NXT1004 NXT1005 NXT1006 NXT1007 NXT1008 NXT1009 NXT1010 NXT1011 NXT1012 NXT1013 NXT1014 NXT1015 NXT1016 NXT1017 NXT1018 NXT1019 NXT1020P NXT1021 NXT1022 NXT1023 NXT1024 NXT1025 NXT1026 NXT1027 NXT1028 NXT1029 NXT1030 NXT1031 NXT1032 NXT1033 NXT1034 NXT1035 NXT1036 NXT1037 NXT1038 NXT1039 NXT1040 NXT1041 NXT1042 NXT1043 NXT1044 NXT1045 NXT1046 NXT1047 NXT1048 NXT1049 NXT1050 NXT1051 NXT1052 NXT1053 NXT1054 NXT1055 NXT1056 NXT1057 NXT1058 NXT1059 NXT1060 NXT1061 NXT1062 NXT1063 NXT1064 NXT1065 NXT1066 NXT1067 NXT1068 NXT1069 NXT1070 NXT1071 NXT1072 NXT1073 (Asia) NXT1074 NXT1075 NXT1076 NXT1077 NXT1078 NXT1079 NXT1080

General and Plastic Surgery Devices

Unclassified

No

Worldwide -- USA (nationwide) and countries of France, Germany, Hungary, Ireland, Italy, Netherlands, Spain, Sweden and Taiwan

Integra CUSA NXT Ultrasonic Tissue Ablation System Service Module || The CUSA NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation. emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. including Neurosurgery. Gastrointestinal and affiliated organ surgery. Urological surgery. Plastic and Reconstructive surgery. General surgery, Orthopedic surgery. Gynecological surgery, Thoracic surgery. laparoscopic surgery and Thoracoscopic surgery.

060111 080111 090111 100811

Radiology Devices

2

No

Worldwide Distribution - United States (nationwide) including the states of: FL, MA, MS, NJ, OH, TN and VA, and the countries of: Canada and Australia.

Other-Sonic Generic Ultrasound Transmission Gel 250 mL || Hypoallergenic || Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.

060111 080111 090111 100811

Radiology Devices

2

No

Worldwide Distribution - United States (nationwide) including the states of: FL, MA, MS, NJ, OH, TN and VA, and the countries of: Canada and Australia.

Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic || Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.