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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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Ultravision2 IonPencil - 05060417680498

The Ultravision2 IonPencil™ is a bifunctional open surgery device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device. It’s addition to the Ultravision2 System adds the general open procedure capability to the Ultravision2™ indications of use along with the new single use accessory.
ALESI SURGICAL LIMITED
DPD-007-001
In Commercial Distribution

  • 15060417680495 ()
  • 05060417680498 ()
  • 25060417680492 ()
DPD-007-001

  • Surgical plume evacuation system

n.a. - 04048551053409

Insertable Suction Tube
Karl Storz GmbH & Co. KG
12067M
In Commercial Distribution

  • 04048551053409 ()
12067M

  • Surgical plume evacuation system

FILTRESSE - H671SSE2000

Smoke Filtration System (230 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
230VAC
In Commercial Distribution

  • H671SSE2000 ()
SSE-200

  • Surgical plume evacuation system

FILTRESSE - H671SSE1000

Smoke Filtration System (115 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
115VAC
In Commercial Distribution

  • H671SSE1000 ()
SSE-100

  • Surgical plume evacuation system

Remora Smoke and Fluid Evacuation System - 00842071139353

Remora Smoke and Fluid Evacuation System Micro (Sterile, Pouched), MDR
APPLIED MEDICAL TECHNOLOGY, INC.
EST9100
In Commercial Distribution

  • 00842071139377 ()
  • 00842071139353 ()
EST9100, ST9100

  • Surgical plume evacuation system

Remora Smoke and Fluid Evacuation System - 00842071139346

Remora Smoke and Fluid Evacuation System (Sterile, Pouched), MDR
APPLIED MEDICAL TECHNOLOGY, INC.
EST9000
In Commercial Distribution

  • 00842071139360 ()
  • 00842071139346 ()
EST9000, ST9000

  • Surgical plume evacuation system

Bovie - 10607151008496

BOVIE EZ LINK
BOVIE MEDICAL CORPORATION
SERS2
In Commercial Distribution

  • 10607151008496 ()
SERS2

  • Surgical plume evacuation system

Bovie - 10607151008304

SMOKE SHARK II 120V-220V - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
SE02-220
In Commercial Distribution

  • 10607151008304 ()
SE02-220

  • Surgical plume evacuation system

Bovie - 10607151008298

SMOKE SHARK II 120 V - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
SE02
In Commercial Distribution

  • 10607151008298 ()
SE02

  • Surgical plume evacuation system

Bovie - 10607151004801

PNEUMATIC FOOTSWITCH - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
FSSEP
In Commercial Distribution

  • 10607151004801 ()
FSSEP

  • Surgical plume evacuation system
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