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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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SICKLE KNIFE DISPOSABLE SINUS ENDOSCOPY
Gyrus ACMI, LLC
130801
In Commercial Distribution

  • 00821925016842 ()
  • 00821925040267 ()


  • Electrosurgical system
PLASMAKINETIC SUPERPULSE SYSTEM Footswitch
Gyrus ACMI, LLC
744010
In Commercial Distribution

  • 00821925039599 ()


  • Electrosurgical system
DIEGO ELITE TUBESET, DECLOG
Gyrus ACMI, LLC
TS101DC
In Commercial Distribution

  • 00821925027824 ()
  • 00821925038820 ()


  • Electrosurgical system
DIEGO ELITE TUBESET, STANDARD
Gyrus ACMI, LLC
TS100S
In Commercial Distribution

  • 00821925027817 ()
  • 00821925038813 ()


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

  • 00821925027893 ()
  • 00821925038660 ()


  • Electrosurgical system
Replacement Knob Assembly (4/PK)
Gyrus ACMI, LLC
RKA-4
In Commercial Distribution

  • 00821925038622 ()
  • 00821925007932 ()


  • 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
PC 12 PLASMAKNIFE DISPOSABLE TIP - 7 CM (6/Pk)
Gyrus ACMI, LLC
70353112
In Commercial Distribution

  • 00821925026728 ()
  • 00821925034754 ()


  • Electrosurgical system
TA² PLASMAKNIFE DISPOSABLE TIP - 7CM (6/Pk)
Gyrus ACMI, LLC
70353107
In Commercial Distribution

  • 00821925026711 ()
  • 00821925034747 ()


  • Electrosurgical system
TA2 PLASMAKNIFE DISPOSABLE TIP (6/Pk)
Gyrus ACMI, LLC
70353100
In Commercial Distribution

  • 00821925026704 ()
  • 00821925034730 ()


  • Electrosurgical system
DISPOSABLE BIPOLAR NASAL CAUTERY - SINGLE USE 18 GAUGE TIP, LG OF TIP 4.0 MM OVERALL LG 175 MM
Gyrus ACMI, LLC
131500
In Commercial Distribution

  • 00821925018655 ()
  • 00821925034433 ()


  • Electrosurgical system
RETURN ELECTRODE NON-STERILE DISTRIBUTED BY GYRUS ACMI INC. DISTRIBUT
Gyrus ACMI, LLC
7201001
In Commercial Distribution

  • 00821925024670 ()
  • 00821925033665 ()


  • Electrosurgical system
VENT TUBE 12 MM LENGTH 1.14 MM I.D. FLUOROPLASTIC
Gyrus ACMI, LLC
140033
In Commercial Distribution

  • 00821925015180 ()
  • 00821925032309 ()


  • Electrosurgical system
VENT TUBE 7 MM LENGTH 0.89 MM I.D. FLUOROPLASTIC
Gyrus ACMI, LLC
140034
In Commercial Distribution

  • 00821925015197 ()
  • 00821925032286 ()


  • Electrosurgical system
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