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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FiberLase GYN LAP-R Handpiece
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
AC-1059620
In Commercial Distribution

  • 00860009714915 ()


  • General/multiple surgical laser system beam guide, reusable
FiberLase GYN LAP-S Handpiece
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
AC-1059630
In Commercial Distribution

  • 00860009714908 ()


  • General/multiple surgical laser system beam guide, reusable
Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 110 mm laser probe with removable stylet and 1 temperature sensor, (1) 110 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in USA/EU/UK.
Novian Health Inc.
USA/EU/UK: 110 mm
In Commercial Distribution

  • 00860008944801 ()
100011-02

  • General/multiple surgical laser system beam guide, single-use
Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 110 mm laser probe with removable stylet and 1 temperature sensor, (1) 110 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in Switzerland.
Novian Health Inc.
Switzerland: 110 mm
In Commercial Distribution

  • 00860008944894 ()
100011-04

  • General/multiple surgical laser system beam guide, single-use
Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 150 mm laser probe with removable stylet and 1 temperature sensor, (1) 150 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in USA/EU/UK
Novian Health Inc.
USA/EU/UK: 150 mm
In Commercial Distribution

  • 00860008944818 ()
100011-01

  • General/multiple surgical laser system beam guide, single-use
Laser Fiber Handpiece Caps (5)
Sentient Manufacturing, LLC
3041330
In Commercial Distribution

  • 00860008856401 ()
  • 00860008856425 ()


  • General/multiple surgical laser system beam guide, reusable
end emitting laser fiber, single use, 550 micron flat tip
WISDOM MEDICAL TECHNOLOGY, LLC
201550-IC
In Commercial Distribution

  • 00859337007202 ()
201550-IC

  • General/multiple surgical laser system beam guide, reusable
end emitting laser fiber, single use, 365 micron flat tip
WISDOM MEDICAL TECHNOLOGY, LLC
201365-IC
In Commercial Distribution

  • 00859337007196 ()
201365-IC

  • General/multiple surgical laser system beam guide, reusable
end emitting laser fiber, single use, 272 micron flat tip
WISDOM MEDICAL TECHNOLOGY, LLC
201272-IC
In Commercial Distribution

  • 00859337007189 ()
201272-IC

  • General/multiple surgical laser system beam guide, reusable
end emitting laser fiber, single use, 200 micron flat tip
WISDOM MEDICAL TECHNOLOGY, LLC
201200-IC
In Commercial Distribution

  • 00859337007172 ()
201200-IC

  • General/multiple surgical laser system beam guide, reusable
lateral emitting laser fiber, single use, 400 micron, radial tip
WISDOM MEDICAL TECHNOLOGY, LLC
101255-IC
In Commercial Distribution

  • 00859337007165 ()
101255-IC

  • General/multiple surgical laser system beam guide, reusable
lateral emitting laser fiber, single use, 600 micron radial tip
WISDOM MEDICAL TECHNOLOGY, LLC
101260-IC
In Commercial Distribution

  • 00859337007158 ()
101260-IC

  • General/multiple surgical laser system beam guide, reusable
lateral emitting laser fiber
WISDOM MEDICAL TECHNOLOGY, LLC
101220-SMA
In Commercial Distribution

  • 00859337007141 ()
101220-SMA

  • General/multiple surgical laser system beam guide, reusable
end emitting laser fiber, single use, 600 micron, SF
WISDOM MEDICAL TECHNOLOGY, LLC
101095-SF IC
In Commercial Distribution

  • 00859337007134 ()
101095-SF IC

  • General/multiple surgical laser system beam guide, reusable
end emitting laser fiber, single use, 600 micron flat tip
WISDOM MEDICAL TECHNOLOGY, LLC
101095-IC
In Commercial Distribution

  • 00859337007127 ()
101095-IC

  • General/multiple surgical laser system beam guide, reusable
MegaBeam® Single Use, Handpiece
WISDOM MEDICAL TECHNOLOGY, LLC
ENT-20-US-IC
In Commercial Distribution

  • 00859337007110 ()
ENT-20-US-IC

  • General/multiple surgical laser system beam guide, reusable
lateral emitting laser fiber
WISDOM MEDICAL TECHNOLOGY, LLC
101258-IC
In Commercial Distribution

  • 00859337007103 ()
101258-IC

  • General/multiple surgical laser system beam guide, reusable
MegaBeam® 400um, Radial Tip, Side Firing laser fiber, single use
WISDOM MEDICAL TECHNOLOGY, LLC
101257-IC
In Commercial Distribution

  • 00859337007097 ()
101257-IC

  • General/multiple surgical laser system beam guide, reusable
Twister 600um SMA, side firing laser fiber, single use
WISDOM MEDICAL TECHNOLOGY, LLC
101257
In Commercial Distribution

  • 00859337007080 ()
101257

  • General/multiple surgical laser system beam guide, reusable
MegaBeam® Single Use, End Emitting, Handpiece 30 Deg.
WISDOM MEDICAL TECHNOLOGY, LLC
AP-400-30
In Commercial Distribution

  • 00859337007073 ()
AP-400-30

  • General/multiple surgical laser system beam guide, reusable
MegaBeam 400um SMA, radial emitting laser fiber, single use
WISDOM MEDICAL TECHNOLOGY, LLC
101256
In Commercial Distribution

  • 00859337007066 ()
101256

  • General/multiple surgical laser system beam guide, reusable
MegaBeam® Single Use, End Emitting, Handpiece 15 Deg.
WISDOM MEDICAL TECHNOLOGY, LLC
AP-400-15
In Commercial Distribution

  • 00859337007059 ()
AP-400-15

  • General/multiple surgical laser system beam guide, reusable
lateral emitting laser fiber
WISDOM MEDICAL TECHNOLOGY, LLC
101300-IC
In Commercial Distribution

  • 00859337007042 ()
101300-IC

  • General/multiple surgical laser system beam guide, reusable
lateral emitting laser fiber
WISDOM MEDICAL TECHNOLOGY, LLC
101175-IC
In Commercial Distribution

  • 00859337007035 ()
101175-IC

  • General/multiple surgical laser system beam guide, reusable
lateral emitting laser fiber
WISDOM MEDICAL TECHNOLOGY, LLC
101315-IC
In Commercial Distribution

  • 00859337007028 ()
101315-IC

  • General/multiple surgical laser system beam guide, reusable
lateral emitting shaped laser fiber, single use
WISDOM MEDICAL TECHNOLOGY, LLC
10102B-IC
In Commercial Distribution

  • 00859337007011 ()
10102B-IC

  • General/multiple surgical laser system beam guide, reusable
lateral emitting shaped laser fiber, single use
WISDOM MEDICAL TECHNOLOGY, LLC
10102B
In Commercial Distribution

  • 00859337007004 ()
10102B

  • General/multiple surgical laser system beam guide, reusable
ESU Grounding Pad (1pack / 25 pack per Box / 8 Box per Case)
Medisourcenet, Inc
MSNCF22
In Commercial Distribution

  • 10850034735150 ()
  • 00850034735153 ()
  • 20850034735157 ()


  • Electrosurgical return electrode, single-use
P9552F-MSN ESU Grounding Pad (1 pack / 25 pack per Box / 8 Box per Case)
Medisourcenet, Inc
P9552F-MSN
In Commercial Distribution

  • 00850034735146 ()
  • 10850034735143 ()
  • 20850034735140 ()


  • Electrosurgical return electrode, single-use
Adler MicroMed Laser Surgery Fiber 3.0 NC 270 HGT 420 RT
ADLER MICROMED, INC.
BFCS000296
In Commercial Distribution

  • 00850348007236 ()
  • 00850348007212 ()
  • 00850348007229 ()
BFCS000296

  • General/multiple surgical laser system beam guide, reusable
Adler MircroMed laser Surgery Fiber 3.0 NC 270 HGT 420
ADLER MICROMED, INC.
BFCS000288
Not in Commercial Distribution

  • 00850348007205 ()
  • 00850348007182 ()
  • 00850348007199 ()
BFCS000288

  • General/multiple surgical laser system beam guide, reusable
Adler MicroMed Laser Surgery Fiber 2.5 NC 600 FSC 1.8
ADLER MICROMED, INC.
SFCS000145
In Commercial Distribution

  • 00850348007038 ()
  • 00850348007151 ()
  • 00850348007090 ()
SFCS000145

  • General/multiple surgical laser system beam guide, reusable
Adler MicroMed Laser Surgery Fiber 3.0 NC 270 GT 420 RT
ADLER MICROMED, INC.
631000296
In Commercial Distribution

  • 00850348007533 ()
  • 00850348007526 ()
  • 00850348007540 ()
631000296

  • General/multiple surgical laser system beam guide, single-use
Adler MicroMed Laser Surgery Fiber 2.5 NC 400 T 750
ADLER MICROMED, INC.
631000304
In Commercial Distribution

  • 00850348007502 ()
  • 00850348007496 ()
  • 00850348007519 ()
631000304

  • General/multiple surgical laser system beam guide, single-use
Adler MicroMed Laser Surgery Luer Lock Fiber 600 um NA 0.37 2.5m
ADLER MICROMED, INC.
631000302
In Commercial Distribution

  • 00850348007472 ()
  • 00850348007465 ()
  • 00850348007489 ()
631000302

  • General/multiple surgical laser system beam guide, single-use
Adler MicroMed Laser Surgery Fiber 3.0 NC 270 HGT 420
ADLER MICROMED, INC.
631000288
In Commercial Distribution

  • 00850348007441 ()
  • 00850348007434 ()
  • 00850348007458 ()
631000288

  • General/multiple surgical laser system beam guide, reusable
Adler MicroMed Laser Surgery Fiber 2.5 NC 600 HSC 1.8
ADLER MICROMED, INC.
635000235
In Commercial Distribution

  • 00850348007410 ()
  • 00850348007403 ()
  • 00850348007427 ()
635000235

  • General/multiple surgical laser system beam guide, single-use
Adler MicroMed Laser Surgery Fiber 2.5 NC 600 RSCF 1.8
ADLER MICROMED, INC.
636000099
In Commercial Distribution

  • 00850348007380 ()
  • 00850348007373 ()
  • 00850348007397 ()
636000099

  • General/multiple surgical laser system beam guide, single-use
Adler MicroMed Laser Surgery Fiber 2.5 NC 600 HSC 1.8
ADLER MICROMED, INC.
SFCS000235
Not in Commercial Distribution

  • 00850348007304 ()
  • 00850348007328 ()
  • 00850348007311 ()


  • General/multiple surgical laser system beam guide, reusable
Adler MicroMed Laser Surgery Fiber 2.5 NC 400 T 750
ADLER MICROMED, INC.
BFCS000304
In Commercial Distribution

  • 00850348007274 ()
  • 00850348007298 ()
  • 00850348007281 ()
BFCS000304

  • General/multiple surgical laser system beam guide, reusable
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