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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 - 00821925040267

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

  • 00821925016842 ()
  • 00821925040267 ()


  • Electrosurgical system

PlasmaKinetic - 00821925039599

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

  • 00821925039599 ()


  • Electrosurgical system

DIEGO ELITE - 00821925038820

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

  • 00821925027824 ()
  • 00821925038820 ()


  • Electrosurgical system

DIEGO ELITE - 00821925038813

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

  • 00821925027817 ()
  • 00821925038813 ()


  • Electrosurgical system

DIEGO ELITE - 00821925038660

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

  • 00821925027893 ()
  • 00821925038660 ()


  • Electrosurgical system

Gyrus ACMI - 00821925038622

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

  • 00821925038622 ()
  • 00821925007932 ()


  • Electrosurgical system

DIEGO ELITE - 00821925038127

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

  • 00821925027886 ()
  • 00821925038127 ()


  • Electrosurgical system

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

Gyrus ACMI - 00821925034754

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

  • 00821925026728 ()
  • 00821925034754 ()


  • Electrosurgical system

Gyrus ACMI - 00821925034747

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

  • 00821925026711 ()
  • 00821925034747 ()


  • Electrosurgical system

Gyrus ACMI - 00821925034730

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

  • 00821925026704 ()
  • 00821925034730 ()


  • Electrosurgical system

Gyrus ACMI - 00821925034433

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

Gyrus ACMI - 00821925033665

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

  • 00821925024670 ()
  • 00821925033665 ()


  • Electrosurgical system

Gyrus ACMI - 00821925032309

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

  • 00821925015180 ()
  • 00821925032309 ()


  • Electrosurgical system

Gyrus ACMI - 00821925032286

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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