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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HALYARD* Multi-COOLED RF Kit
Avanos Medical, Inc.
40608
In Commercial Distribution

  • 10680651406085 ()
MCK2-17-75-4

  • Neurosurgical procedure kit, non-medicated, single-use
  • Radio-frequency ablation system
HALYARD* Multi-COOLED RF Kit
Avanos Medical, Inc.
40589
In Commercial Distribution

  • 10680651405897 ()
MCK3-17-75-4

  • Neurosurgical procedure kit, non-medicated, single-use
  • Radio-frequency ablation system
The Venus Viva system is intended for dermatological procedures requiring ablation and resurfacing of the skin.
VENUS CONCEPT LTD
VI102402
In Commercial Distribution

  • 07290016540307 ()


  • Radio-frequency skin surface treatment system
An assortment kit containing a combination of uninitiated and pre-initiated laser tips intended for use with Biolase diode lasers only. The tips have the same core diameter of 400 microns and different lenghts. The tips are non-sterile for single use only and require sterilization prior to use.
Biolase, Inc.
Diode Laser Tips - Starter Kit
Not in Commercial Distribution

  • 00647529004005 ()

  • Length: 9 Millimeter
  • Length: 7 Millimeter
  • Length: 4 Millimeter
  • Outer Diameter: 400 Micrometer
6400165

  • General/multiple surgical laser system beam guide, single-use, non-sterile
A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems.
Biolase, Inc.
Pre-initiated, Perio, 4-7
In Commercial Distribution

  • 00647529003381 ()
  • 00647529003329 ()

  • Outer Diameter: 400 Micrometer
  • Length: 7 Millimeter
7400068

  • General/multiple surgical laser system beam guide, single-use, non-sterile
A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems.
Biolase, Inc.
Pre-initiated, Surgical, 4-4
In Commercial Distribution

  • 00647529003374 ()
  • 00647529003312 ()

  • Length: 4 Millimeter
  • Outer Diameter: 400 Micrometer
7400067

  • General/multiple surgical laser system beam guide, single-use, non-sterile
A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems.
Biolase, Inc.
Pre-Initiated, Perio, 3-9
In Commercial Distribution

  • 00647529003367 ()
  • 00647529003305 ()

  • Length: 9 Millimeter
  • Outer Diameter: 300 Micrometer
7400065

  • General/multiple surgical laser system beam guide, single-use, non-sterile
An assortment kit containing 30 single-use pre-initiated tips intended for use with diode laser delivery systems. The tips vary in length and core diameter.
Biolase, Inc.
EpiTips Surgical Assortment
Not in Commercial Distribution

  • 00647529001967 ()
6400564

  • General/multiple surgical laser system beam guide, single-use, non-sterile
A tip kit containing 30 single-use laser tips intended for use with Biolase diode laser systems. The tips have the same core diameter of 300 microns and vary in length.
Biolase, Inc.
Perio EZ Tips Combo Pack, E3
In Commercial Distribution

  • 00647529001820 ()

  • Outer Diameter: 300 Micrometer
  • Length: 7 Millimeter
  • Length: 9 Millimeter
7400020

  • General/multiple surgical laser system beam guide, single-use, non-sterile
A tip kit containing 30 single-use laser tips intended for use with diode laser systems. The tips have the same core diameter of 400 microns and vary in length.
Biolase, Inc.
Perio EZ Tips Combo Pack, E4
In Commercial Distribution

  • 00647529001813 ()

  • Length: 9 Millimeter
  • Length: 7 Millimeter
  • Outer Diameter: 400 Micrometer
7400019

  • General/multiple surgical laser system beam guide, single-use, non-sterile
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