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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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HIVOCAUTER, MONO-TERMINAL AND BI-TERMINAL
ELMED INCORPORATED
5240
In Commercial Distribution

  • 00842180105928 ()
5240

  • Electrosurgical system generator
ELMED ESU 70 ELECTROSURGICAL UNIT WITH MONOPOLAR FOOTSWITCHING SMART-MATIC CIRCUIT, INCLUDES FOOTSWITCH
ELMED INCORPORATED
5195
In Commercial Distribution

  • 00842180105904 ()
5195

  • Electrosurgical system generator
ELMED ESU 100E M/M MONOPOLAR / BIPOLAR UNIT WITH MONOPOLAR OUTPUT DISPLAY, MICRO/MACRO CIRCUITS, ARFM MONITOR, DOUBLE PEDAL FOOTSWITCH OPERATION WITH SELECTOR SWITCH
ELMED INCORPORATED
52-5770-02
In Commercial Distribution

  • 00842180107946 ()
52-5770-02

  • Electrosurgical system generator
"ELMED SYSTEM FOR BIPOLAR SUBMUCOSAL TURBINATE SURGERY CONSISTING OF: LIST NO. 5300 ELMED BC 50 M/M GENERATOR, LIST NO. 5970 DENNIS TURBINATE PROBE, LIST NO. 5707 FOOTSWITCH, LIST NO. 5302 BIPOLAR RF-CABLE, LIST NO. 55200-03 STERILIZATION AND STORAGE CASE AND LIST NO. 5975 INSTRUCTIONAL VIDEO TAPE"
ELMED INCORPORATED
5984
In Commercial Distribution

  • 00842180106802 ()
5984

  • Electrosurgical system generator
LBC 50-P BIPOLAR COAGULATOR WITH ARFM COAGULATION MONITOR + DIGITAL WATTAGE DISPLAY
ELMED INCORPORATED
52-5671
In Commercial Distribution

  • 00842180106215 ()
52-5671

  • Electrosurgical system generator
ESU 70 B ENT II PACKAGE: INCLUDES ESU 70 B, SINGLE PEDAL FOOTSWITCH (#5707), REUSABLE PATIENT PLATE (#5047), RUBBER STRAP FOR PATIENT PLATE (#5044), PATIENT PLATE CONNECTING CABLE (#5701), SUCTION COAGULATION HANDLE (#5241), SUCTION COAGULATION EXTENSION (#5242), MICRO HANDLE (#5010), NEEDLE ELECTRODE (#5606-05), BLADE ELECTRODE (#5607-05), MONOPOLAR RF-CABLE (#5021), DENNIS BIPOLAR PROBE (#5970), BIPOLAR CABLE (#5230), ELMED EQUIPMENT TROLLEY (#4755)
ELMED INCORPORATED
5196 ENT II
In Commercial Distribution

  • 00842180106208 ()
5196 ENT II

  • Electrosurgical system generator
ESU 70 B ENT I PACKAGE: CONSISTING OF (1) 5196 ESU 70 B GENERATOR, (1) 5701 FOOTSWITCH, (1) 5747 PATIENT PLATE, (1) 5701 PATIENT PLATE RETURN CABLE, (1) 5044 RETAINING STRAP
ELMED INCORPORATED
5196 ENT I
In Commercial Distribution

  • 00842180106192 ()
5196 ENT I

  • Electrosurgical system generator
ELMED ESU 120 M/M DIGITAL SYSTEM ELECTROSURGICAL UNIT, FOOTSWITCHING SMART-O-MATIC CIRCUIT FOR MONOPOLAR, BIPOLAR AND RADIO FREQUENCY THERMAL ABLATION (RFTA) MICRO MODE, INCLUDES FOOTSWITCH
ELMED INCORPORATED
5797
In Commercial Distribution

  • 00842180106031 ()
5797

  • Electrosurgical system generator
ELMED ESU 400 DIGITAL WITH SMART-O-MATIC CIRCUIT, MONOPOLAR AND BIPOLAR, WITH RETURN ELECTRODE MONITOR (REM), COMPATIBLE WITH DUAL-CONTACT PATIENT PLATES
ELMED INCORPORATED
5759
In Commercial Distribution

  • 00842180106024 ()
5759

  • Electrosurgical system generator
ELMED ESU 400 DIGITAL WITH SMART-O-MATIC CIRCUITM MONOPOLAR AND BIPOLAR
ELMED INCORPORATED
5758
In Commercial Distribution

  • 00842180106017 ()
5758

  • Electrosurgical system generator
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