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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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Gyrus ACMI - 00821925037977

Somnoplasty Model 1120, Electrode (5/Pk)
Gyrus ACMI, LLC
1120-4110-05
In Commercial Distribution

  • 00821925010727 ()
  • 00821925037977 ()


  • Electrosurgical system

Gyrus ACMI - 00821925037960

Somnoplasty Model 1010 (5/Pk)
Gyrus ACMI, LLC
1010-2110-05
In Commercial Distribution

  • 00821925010833 ()
  • 00821925037960 ()


  • Electrosurgical system

Bovie - 00821925037762

Endoscopic Cord 10 FT (304.8 cm)
Gyrus ACMI, LLC
5142708
In Commercial Distribution

  • 00821925010130 ()
  • 00821925037762 ()


  • Electrosurgical system

GYRUS ACMI, INC - 00821925037687

DISPOSABLE BIPOLAR CORD SINGLE USE SUPER FLEXIBLE LENGTH 12.0' DISTRIBUTED BY GYRUS ENT
Gyrus ACMI, LLC
131510
In Commercial Distribution

  • 00821925017832 ()
  • 00821925037687 ()


  • Electrosurgical system

USA Elite - 00821925036369

USA Elite System and USA Series Disposable Active Cord
Gyrus ACMI, LLC
DAC
In Commercial Distribution

  • 00821925009721 ()
  • 00821925036369 ()


  • Electrosurgical system

Olympus - 00821925035867

PK CUTTING FORCEPS, 5 mm, 33 cm (5/PK)
Gyrus ACMI, LLC
PK-CF0533
In Commercial Distribution

  • 00821925035850 ()
  • 00821925035867 ()


  • Electrosurgical system

Electrosurgical Unit - 00818354013030

Electrosurgical Unit (115V)
ATRICURE, INC.
001-604-4810B
In Commercial Distribution

  • 00818354013030 ()


  • Electrosurgical system

SURTRON - 08033638321911

SURTRON device model 400HP is an ElectroSurgical Unit including monopolar and bipolar technology. SURTRON 400HP is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. Maximum output power is 400W and frequency of 425kHz.
LED SPA
400HP
In Commercial Distribution

  • 08033638321911 ()
10400.902/US

  • Electrosurgical system

SURTRON - 08033638321164

SURTRON device model 160HF is an ElectroSurgical Unit including monopolar and bipolar technology. SURTRON 160HF is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. Maximum output power is 150W and frequency of 4MHz.
LED SPA
160HF
In Commercial Distribution

  • 08033638321164 ()
10300.201/US

  • Electrosurgical system

SURTRON - 08033638321140

SURTRON device model 200 is an ElectroSurgical Unit including monopolar and bipolar technology. SURTRON 200 is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. Maximum output power is 200W and frequency of 600kHz.
LED SPA
200
In Commercial Distribution

  • 08033638321140 ()
10100.401/US

  • Electrosurgical system
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