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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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RFA Generator,220 V
Covidien LP
CTRF 220
Not in Commercial Distribution

  • 10884524002781 ()


  • Tumour-therapy radio-frequency hyperthermia system
RFA Generator,100 V
Covidien LP
CTRF 100
Not in Commercial Distribution

  • 10884524002774 ()


  • Tumour-therapy radio-frequency hyperthermia system
The patient cable, ST-PTCBL is the component of SENSITHERM MULTI System which connects the main unit to the disposable temperature probe ST-PROBE. The handle at one end of the cable contains both the electronic circuits which digitize the temperatures and the components that make SENSITHERM MULTI System immune to the effects of a defibrillator discharge and other EMC disturbances. An contact custom socket on one side of the handle allows the user to connect the ST-PTCBL to a mapping system using the cable ST-ADPT-30.
FIAB SPA
ST-PTCBL
In Commercial Distribution

  • 08058480754700 ()
ST-PTCBL

  • Oesophageal temperature monitor
ST-MONITOR is a device for monitoring of esophageal temperature on three different points; moreover it allows setting of temperature threshold alarm value between 36°C and 41°C. ST-MONITOR is equipped with three high precision thermometers to be connected, through an appropriate cable and connector, to the ST-PROBE. Using this device it is possible to follow, in immediate and precise way, the rise of the temperature inside the esophagous. The incorporated alarm system allows to the operator to set an adequate threshold temperature. A buzzer and a flashing led signal the exceeding the temperatures of the threshold value alarm, the temperature and alarm signals can be sent to an external display and recording system through output signal connector. Sensitherm Multi System is intended for continue esophageal temperature monitoring and it consists of 3 components: ST-MONITOR, Patient Cable (ST-PTCBL model number) and Probe (ST-PROBE model number).
FIAB SPA
ST-MONITOR
In Commercial Distribution

  • 08058480754021 ()
ST-MONITOR

  • Oesophageal temperature monitor
Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer
Gynesonics, Inc.
IUSP-002
In Commercial Distribution

  • 30817929020092 ()
  • 10817929020098 ()
IUSP-002

  • Ultrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer, reusable
The Anovo Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit). The Anovo Instrument ARMS are the system’s components that are inserted transvaginally into the pelvic cavity to manipulate the tissue and perform the surgery. Two identical Instrument ARMS are connected to the Robotic Control Units, each of which corresponds to the respective hand of the surgeon as controlled by right or left Controllers. The two Arms utilized with the Anovo System are identical and provide identical capabilities. The end effector, located at the end of the flexible section, provides grasping and electrosurgical capabilities. The Instrument Arm is a sterile disposable component. It is ETO sterilized and provided to the user within a plastic tray packaged in a sterile pouch. Instrument ARMS Packed with Cannula Seal & ARMS Entry Guide Seal
MOMENTIS SURGICAL LTD
-
In Commercial Distribution

  • 17290018151096 ()
  • 27290018151093 ()
FP-01-0001

  • Robotic electrosurgical instrument, bipolar/monopolar
RFA Switching Controller
Covidien LP
CTSW Control
Not in Commercial Distribution

  • 10884524002798 ()


  • Tumour-therapy radio-frequency hyperthermia system
No Description
CLASSYS Inc.
FRX-C2
In Commercial Distribution

  • 08800016903621 ()


  • Dermatological carbon dioxide laser system
  • Intradermal radio-frequency ablation system
Biopsy Fcps, Oval, Monopolar, 5mm, 35cm
TELEFLEX INCORPORATED
IPN009535
In Commercial Distribution

  • 14026704649614 ()
728034

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
No Description
AMERICAN MEDICAL ENDOSCOPY, INC.
STS-LAP-305-00
In Commercial Distribution

  • 00851925007892 ()


  • Endoscopic electrosurgical electrode, bipolar, reusable
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