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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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SHAVER BLADE, SMR STANDARD, TYPE A DIEGO ELITE
Gyrus ACMI, LLC
SB2000SA
In Commercial Distribution

  • 00821925027893 ()
  • 00821925038660 ()


  • Electrosurgical system
SHAVER BLADE, SMR BIPOLAR, TYPE A DIEGO ELITE
Gyrus ACMI, LLC
BB2000SA
In Commercial Distribution

  • 00821925027886 ()
  • 00821925038127 ()


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

  • 00821925010727 ()
  • 00821925037977 ()


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

  • 00821925010833 ()
  • 00821925037960 ()


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

  • 00821925010130 ()
  • 00821925037762 ()


  • Electrosurgical system
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 System and USA Series Disposable Active Cord
Gyrus ACMI, LLC
DAC
In Commercial Distribution

  • 00821925009721 ()
  • 00821925036369 ()


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

  • 00821925035850 ()
  • 00821925035867 ()


  • Electrosurgical system
BiPolar Connector Cord
Gyrus ACMI, LLC
3998-100
In Commercial Distribution

  • 00821925009677 ()


  • Electrosurgical system
Bipolar Cable, 12'
Gyrus ACMI, LLC
568618
In Commercial Distribution

  • 00821925008304 ()


  • Electrosurgical system
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