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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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Dornier SingleFlex 400 High Energy Laser Fiber - Dornier Direct
DORNIER MEDTECH AMERICA, INC.
400 Micron Single Use HE
In Commercial Distribution

  • 00810116020812 ()
  • 00810116020751 ()
HOL400SHE

  • General/multiple surgical laser system beam guide, single-use
Dornier SingleFlex 200 High Energy Laser Fiber - Dornier Direct
DORNIER MEDTECH AMERICA, INC.
200 Micron Single Use HE
In Commercial Distribution

  • 00810116020737 ()
  • 00810116020799 ()
HOL200SHE

  • General/multiple surgical laser system beam guide, single-use
400 micron core/730 micron OD SMA Diode Laser Fiber, 3.5 meters
DORNIER MEDTECH AMERICA, INC.
400 micron single use SMA
In Commercial Distribution

  • 00810116022564 ()
  • 00810116022571 ()
K2311577

  • General/multiple surgical laser system beam guide, single-use
400 micron core/730 micron OD Luer Lock Diode Laser Fiber, 2.5 meters
DORNIER MEDTECH AMERICA, INC.
400 micron single use luer lock
In Commercial Distribution

  • 00810116022533 ()
  • 00810116022526 ()
K2311822

  • General/multiple surgical laser system beam guide, single-use
600 micron core/730 micron OD Luer Lock Diode Laser Fiber, 3.5 meters
DORNIER MEDTECH AMERICA, INC.
600 micron slim single use luer lock
In Commercial Distribution

  • 00810116022441 ()
  • 00810116022458 ()
K2312393

  • General/multiple surgical laser system beam guide, single-use
600 micron core/1040 micron OD Luer Lock Diode Laser Fiber, 3.5 meters
DORNIER MEDTECH AMERICA, INC.
600 micron single use luer lock
In Commercial Distribution

  • 00810116022397 ()
  • 00810116022380 ()
K2308084

  • General/multiple surgical laser system beam guide, single-use
Dornier SmartFlex 1000 High Energy Laser Fiber - Dornier Direct
DORNIER MEDTECH AMERICA, INC.
1000 Micron Reusable HE
In Commercial Distribution

  • 00810116021123 ()
  • 00810116021079 ()
HOL1000RHE

  • General/multiple surgical laser system beam guide, reusable
Dornier SmartFlex 400 High Energy Laser Fiber - Dornier Direct
DORNIER MEDTECH AMERICA, INC.
400 Micron Reusable HE
In Commercial Distribution

  • 00810116021109 ()
  • 00810116021055 ()
HOL400RHE

  • General/multiple surgical laser system beam guide, reusable
Dornier SmartFlex 270 High Energy Laser Fiber - Dornier Direct
DORNIER MEDTECH AMERICA, INC.
270 Micron Reusable HE
In Commercial Distribution

  • 00810116021093 ()
  • 00810116021048 ()
HOL270RHE

  • General/multiple surgical laser system beam guide, reusable
Dornier SingleFlex 270 High Energy Laser Fiber - Dornier Direct
DORNIER MEDTECH AMERICA, INC.
270 Micron Single Use HE
In Commercial Distribution

  • 00810116020744 ()
  • 00810116020805 ()
HOL270SHE

  • General/multiple surgical laser system beam guide, single-use
Dornier 200 GentleFlex High Energy Laser Fiber - Dornier Direct
DORNIER MEDTECH AMERICA, INC.
200 Micron Ball Tip Single Use HE
In Commercial Distribution

  • 00810116020720 ()
  • 00810116020782 ()
HOL200SBTHE

  • General/multiple surgical laser system beam guide, single-use
Reusable 10x Surgical Optical Fiber ø 365 µm. Distributed by Olympus Surgical Technologies America. Gyrus ACMI, Inc.
QUANTA SYSTEM SPA
EMP-FBX365HR
In Commercial Distribution

  • 08033945938772 ()
  • 08033945938635 ()
  • 08033945938499 ()


  • General/multiple surgical laser system beam guide, reusable
Reusable 10x Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologies America. Gyrus ACMI, Inc.
QUANTA SYSTEM SPA
EMP-FBX272HR
In Commercial Distribution

  • 08033945938765 ()
  • 08033945938628 ()
  • 08033945938482 ()


  • General/multiple surgical laser system beam guide, reusable
Reusable 10x Surgical Optical Fiber ø 200µm. Distributed by Olympus Surgical Technologies America. Gyrus ACMI, Inc.
QUANTA SYSTEM SPA
EMP-FBX200HR
In Commercial Distribution

  • 08033945938758 ()
  • 08033945938611 ()
  • 08033945938475 ()


  • General/multiple surgical laser system beam guide, reusable
Reusable 10x Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologies America. Gyrus ACMI, Inc.
QUANTA SYSTEM SPA
OFH002713
Not in Commercial Distribution

  • 08033945938277 ()
  • 08033945938260 ()
  • 08033945938253 ()
EMP-FBX272HR-C

  • General/multiple surgical laser system beam guide, reusable
Reusable 10x Surgical Optical Fiber ø 365 µm. Distributed by Olympus Surgical Technologies America. Gyrus ACMI, Inc.
QUANTA SYSTEM SPA
OFH703613
Not in Commercial Distribution

  • 08033945938178 ()
  • 08033945938161 ()
  • 08033945938154 ()
EMP-FBX365HR

  • General/multiple surgical laser system beam guide, reusable
Reusable 10x Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologies America. Gyrus ACMI, Inc.
QUANTA SYSTEM SPA
OFH702713
Not in Commercial Distribution

  • 08033945938116 ()
  • 08033945938109 ()
  • 08033945938093 ()
EMP-FBX272HR

  • General/multiple surgical laser system beam guide, reusable
Reusable 10x Surgical Optical Fiber ø 1000 µm. Distributed by Olympus Surgical Technologies America. Gyrus ACMI, Inc.
QUANTA SYSTEM SPA
OFH009913
Not in Commercial Distribution

  • 08033945937966 ()
  • 08033945937959 ()
  • 08033945937942 ()
EMP-FBX1000HR

  • General/multiple surgical laser system beam guide, reusable
Reusable 10x Surgical Optical Fiber ø 550 µm. Distributed by Olympus Surgical Technologies America. Gyrus ACMI, Inc.
QUANTA SYSTEM SPA
OFH005513
Not in Commercial Distribution

  • 08033945937843 ()
  • 08033945937836 ()
  • 08033945937829 ()
EMP-FBX550HR

  • General/multiple surgical laser system beam guide, reusable
Reusable 10x Surgical Optical Fiber ø 200µm. Distributed by Olympus Surgical Technologies America. Gyrus ACMI, Inc.
QUANTA SYSTEM SPA
OFH002013
Not in Commercial Distribution

  • 08033945937720 ()
  • 08033945937713 ()
  • 08033945937706 ()
EMP-FBX200HR

  • General/multiple surgical laser system beam guide, reusable
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