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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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DM DI Different from Primary DI - Yes DM DIs: 07290109143002 07290109142814 07290109142821
LUMENIS LTD.
OtoLase™ Starter Kit
In Commercial Distribution

  • 07290109142807 ()
AC-2003748

  • General/multiple surgical laser system beam guide, reusable
No Description
LUMENIS LTD.
SS FiberLase™ Accessory Starter Kit with FiberLase Fiber
In Commercial Distribution

  • 07290109142517 ()
KT-2064910

  • General/multiple surgical laser system beam guide, single-use
No Description
LUMENIS LTD.
FiberLase™ CO2 Fiber
In Commercial Distribution

  • 07290109142012 ()
AC-1059590

  • General/multiple surgical laser system beam guide, single-use
No Description
LUMENIS LTD.
OtoLase™ Fiber
In Commercial Distribution

  • 07290109141862 ()

  • Lumen/Inner Diameter: 250 Micrometer
  • Length: 2 Meter
AC-20055370

  • General/multiple surgical laser system beam guide, reusable
Additional DM UDI: 07290109144085; 07290109144092
LUMENIS LTD.
SurgiTouch™ Scanning Handpiece 200mm
Not in Commercial Distribution

  • 07290109141510 ()
  • 07290109144078 ()
AA2778200

  • General/multiple surgical laser system beam guide, reusable
Additional DM UDI: 07290109144115; 07290109144122
LUMENIS LTD.
SurgiTouch™ Scanning Handpiece 125mm
Not in Commercial Distribution

  • 07290109141503 ()
  • 07290109144108 ()
AA2814900

  • General/multiple surgical laser system beam guide, reusable
Additional DM UDI: 07290109144054; 07290109144061; 07290109144047; 07290109144078;
LUMENIS LTD.
SurgiTouch™ Scanning Handpiece Set
Not in Commercial Distribution

  • 07290109141480 ()
  • 07290109144122 ()
AA2775200

  • General/multiple surgical laser system beam guide, reusable
No Description
LUMENIS LTD.
SS FiberLase™ HP-M 240 mm malleable
In Commercial Distribution

  • 07290109141305 ()
  • 07290109143774 ()
AC-2083950

  • General/multiple surgical laser system beam guide, reusable
No Description
LUMENIS LTD.
SS FiberLase™ HP-M 300 mm malleable
In Commercial Distribution

  • 07290109141299 ()
  • 07290109143774 ()
AC-2001200

  • General/multiple surgical laser system beam guide, reusable
No Description
LUMENIS LTD.
SS FiberLase™ HP-M 140 mm malleable
In Commercial Distribution

  • 07290109141282 ()
  • 07290109143774 ()
AC-2083940

  • General/multiple surgical laser system beam guide, reusable
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