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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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Premier Filter Pack for Premier Evacuator. Contains five disposable Premier filters.
DERMATOLOGIC LAB AND SUPPLY, INC.
9006290
In Commercial Distribution

  • D69190062901 ()
  • D69190062900 ()
9006290

  • Surgical plume evacuation system
Smoke Filtration System (230 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
230VAC
In Commercial Distribution

  • H671SSE2000 ()
SSE-200

  • Surgical plume evacuation system
Smoke Filtration System (115 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
115VAC
In Commercial Distribution

  • H671SSE1000 ()
SSE-100

  • Surgical plume evacuation system
Insufflation Filter & Tubing Set w/Luer Lock and Silicone tube adapter
ORANGE SURGICAL INSTRUMENTS, LLC
OSITLS
Not in Commercial Distribution

  • B354OSITLS10 ()
  • B354OSITLS0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
No Description
ORANGE SURGICAL INSTRUMENTS, LLC
OSITLPF
Not in Commercial Distribution

  • B354OSITLPF10 ()
  • B354OSITLPF0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
Insufflation Filter & Tubing Set w/O-Ring Quick Connector
ORANGE SURGICAL INSTRUMENTS, LLC
OSITLQ
Not in Commercial Distribution

  • B354OSITLQ10 ()
  • B354OSITLQ0 ()


  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Insufflation Filter & Tubing Set w/2 Luer Locks
ORANGE SURGICAL INSTRUMENTS, LLC
OSITLL
Not in Commercial Distribution

  • B354OSITLL10 ()
  • B354OSITLL0 ()


  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Insufflation Filter & Tubing Set w/Combo 15/22 Connector Heat Activated
ORANGE SURGICAL INSTRUMENTS, LLC
OSITL1522H
Not in Commercial Distribution

  • B354OSITL1522H10 ()
  • B354OSITL1522H0 ()


  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Insufflation Filter & Tubing Set w/Combo 15/22 Connector
ORANGE SURGICAL INSTRUMENTS, LLC
OSITL1522
Not in Commercial Distribution

  • B354OSITL152210 ()
  • B354OSITL15220 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
No Description
Vascular Solutions, Inc.
7787
Not in Commercial Distribution

  • M20677870 ()


  • General surgical procedure kit, non-medicated, single-use
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