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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A tip kit containing 3 reusable laser tips intended for use with Waterlase laser delivery systems. The tips have the same core diameter of 600 microns and vary in length.
Biolase, Inc.
MG6
In Commercial Distribution

  • 00647529000694 ()

  • Outer Diameter: 600 Micrometer
  • Length: 6 Millimeter
  • Length: 4 Millimeter
7200615

  • General/multiple surgical laser system beam guide, reusable
A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems.
Biolase, Inc.
MT4-6
In Commercial Distribution

  • 00647529000670 ()
  • 00647529001998 ()
  • 00647529001981 ()

  • Outer Diameter: 400 Micrometer
  • Length: 6 Millimeter


  • General/multiple surgical laser system beam guide, reusable
A reusable fiberoptic tip accessory intended for use with Waterlase laser delivery systems.
Biolase, Inc.
MX9
In Commercial Distribution

  • 00647529000588 ()
  • 00647529001585 ()

  • Outer Diameter: 900 Micrometer
  • Length: 2 Millimeter


  • General/multiple surgical laser system beam guide, reusable
A reusable fiberoptic tip accessory intended for use with Waterlase laser delivery systems.
Biolase, Inc.
MX11
In Commercial Distribution

  • 00647529000571 ()
  • 00647529001592 ()

  • Outer Diameter: 1100 Micrometer
  • Length: 2 Millimeter


  • General/multiple surgical laser system beam guide, reusable
A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems.
Biolase, Inc.
MX7
In Commercial Distribution

  • 00647529000540 ()
  • 00647529000953 ()

  • Outer Diameter: 700 Micrometer
  • Length: 2 Millimeter


  • General/multiple surgical laser system beam guide, reusable
A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems.
Biolase, Inc.
MX5
In Commercial Distribution

  • 00647529000526 ()
  • 00647529000946 ()

  • Outer Diameter: 500 Micrometer
  • Length: 2 Millimeter


  • General/multiple surgical laser system beam guide, reusable
A tip starting kit containing 22 different laser tips, intended for use with Waterlase laser delivery systems. The tips vary in type, length and core diameter.
Biolase, Inc.
7200831
In Commercial Distribution

  • 00647529000380 ()


  • General/multiple surgical laser system beam guide, reusable
A grounding pad is placed on the body (usually the thigh) before the surgery to protect the person from the harmful effects of the electricity.
DISTRIBUTION UNLIMITED, LLC
1
In Commercial Distribution

  • 10850014433168 ()
  • 00850014433161 ()
  • 20850014433165 ()
DU2100

  • Electrosurgical return electrode, single-use
SureGuide, 2.75m Fiber Cable Assembly, ST Connector
Clinicon Corporation
4143
In Commercial Distribution

  • 00850013050185 ()


  • General/multiple surgical laser system beam guide, single-use
SureGuide, 2.75m Fiber Cable Assembly,SMA with Interlock Wire
Clinicon Corporation
3156
In Commercial Distribution

  • 00850013050178 ()


  • General/multiple surgical laser system beam guide, single-use
SureGuide, 2.00m Fiber Cable Assembly, ST Connector
Clinicon Corporation
4140
In Commercial Distribution

  • 00850013050161 ()


  • General/multiple surgical laser system beam guide, single-use
SureGuide, 2.00m Fiber Cable Assembly, SMA Connector with Interlock Wire
Clinicon Corporation
4034
In Commercial Distribution

  • 00850013050154 ()


  • General/multiple surgical laser system beam guide, single-use
SureTip, GEN, 10mm, straight tip
Clinicon Corporation
3728
In Commercial Distribution

  • 00850013050123 ()


  • General/multiple surgical laser system beam guide, single-use
SureTouch, 1.5mm Universal HandPiece (UHP)
Clinicon Corporation
4012
In Commercial Distribution

  • 00850013050116 ()


  • General/multiple surgical laser system beam guide, single-use
SureProbe ENT, Oto, 70mm Single Curve Assembly
Clinicon Corporation
4011
In Commercial Distribution

  • 00850013050093 ()


  • General/multiple surgical laser system beam guide, single-use
SureProbe ENT, Larynx, 240mm Malleable Dissecting Tip Assembly
Clinicon Corporation
4149
In Commercial Distribution

  • 00850013050086 ()


  • General/multiple surgical laser system beam guide, single-use
SureProbe ENT, Pedriatric, Larynx, 140mm Malleable Dissecting Tip Assembly
Clinicon Corporation
4159
In Commercial Distribution

  • 00850013050079 ()


  • General/multiple surgical laser system beam guide, single-use
SureProbe ENT, 80mm, Oral, Single Curved Dissecting Tip Assembly
Clinicon Corporation
4004
In Commercial Distribution

  • 00850013050062 ()


  • General/multiple surgical laser system beam guide, single-use
SureProbe ENT, 80mm, Oral, Straight Dissecting Tip Assembly
Clinicon Corporation
4008
In Commercial Distribution

  • 00850013050055 ()


  • General/multiple surgical laser system beam guide, single-use
SureProbe, ENT, 50mm, Nasal, Single Curved Dissecting Tip Assembly
Clinicon Corporation
4003
In Commercial Distribution

  • 00850013050048 ()


  • General/multiple surgical laser system beam guide, single-use
SureProbe, ENT, 50mm, Nasal Straight Dissecting Tip Assembly
Clinicon Corporation
4007
In Commercial Distribution

  • 00850013050031 ()


  • General/multiple surgical laser system beam guide, single-use
SureProbe, Neuro, 80mm Straight Dissecting Tip Assembly Copy
Clinicon Corporation
4002
In Commercial Distribution

  • 00850013050024 ()


  • General/multiple surgical laser system beam guide, single-use
SureProbe, Neuro, 50mm Straight Dissecting Tip Assembly
Clinicon Corporation
4001
In Commercial Distribution

  • 00850013050017 ()


  • General/multiple surgical laser system beam guide, single-use
SureProbe, Neuro, 40mm Straight Dissecting Tip Assembly
Clinicon Corporation
4000
In Commercial Distribution

  • 00850013050000 ()


  • General/multiple surgical laser system beam guide, single-use
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
A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno).
Biolase, Inc.
Tip Assembly - Two-17mm, WL JUNO
In Commercial Distribution

  • 00647529003589 ()
  • 00647529004081 ()
  • 00647529004210 ()

  • Length: 17 Millimeter
  • Outer Diameter: 320 Micrometer
6200181

  • General/multiple surgical laser system beam guide, reusable
A reusable fiberoptic tip accessory intended for use with Waterlase All-Tissue Laser Systems. The tip is made of sapphire and is packaged individually in plastic cases.
Biolase, Inc.
Side Firing Tips, SFT8-18
In Commercial Distribution

  • 00647529003626 ()
  • 00647529003602 ()
  • 00647529003619 ()

  • Length: 18 Millimeter
  • Outer Diameter: 800 Micrometer


  • General/multiple surgical laser system beam guide, reusable
A reusable fiberoptic tip accessory intended for use with Waterlase laser delivery systems.
Biolase, Inc.
Side Firing Tips
Not in Commercial Distribution

  • 00647529003459 ()
  • 00647529003442 ()
  • 00647529003527 ()
  • 00647529003510 ()

  • Outer Diameter: 800 Micrometer
  • Length: 18 Millimeter


  • General/multiple surgical laser system beam guide, reusable
A tip kit containing 2 reusable sapphire tips, type C, intended for use with Waterlase laser delivery systems. The tips have the same length of 9 mm and vary in core diameter.
Biolase, Inc.
C Tip Combo
In Commercial Distribution

  • 00647529002995 ()

  • Length: 9 Millimeter
  • Outer Diameter: 320 Micrometer
  • Outer Diameter: 600 Micrometer
7000684

  • General/multiple surgical laser system beam guide, reusable
A training kit containing 11 different laser tips intended for use with Waterlase laser delivery systems. The tips vary in type, length and core diameter.
Biolase, Inc.
7000825
In Commercial Distribution

  • 00647529002940 ()
7000825

  • General/multiple surgical laser system beam guide, reusable
Suggested weight: >15kg
Baylis Médicale Cie Inc
RFA-GP-BAY
Not in Commercial Distribution

  • 20685447001021 ()
  • 10685447001024 ()
  • 00685447001027 ()


  • Electrosurgical return electrode, 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 Switzerland.
Novian Health Inc.
Switzerland: 150 mm
In Commercial Distribution

  • 00860011448006 ()
100011-03

  • General/multiple surgical laser system beam guide, single-use
Re-usable fiberoptic handpiece for lasers
LASER ENGINEERING
OTO Handpiece
In Commercial Distribution

  • 00860011139706 ()
1059746

  • General/multiple surgical laser system beam guide, reusable
SS FiberLase GYN LAP-S Handpiece
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
AC-2059630
In Commercial Distribution

  • 00860009714946 ()


  • General/multiple surgical laser system beam guide, reusable
SS FiberLase GYN LAP-R Handpiece
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
AC-2059620
In Commercial Distribution

  • 00860009714939 ()


  • General/multiple surgical laser system beam guide, reusable
Cleaning Kit for FiberLase GYN Lap Handpieces
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
AC-1059640
In Commercial Distribution

  • 00860009714922 ()
  • 10860009714929 ()


  • General/multiple surgical laser system beam guide, reusable
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 Switzerland.
Novian Health Inc.
Switzerland: 110 mm
In Commercial Distribution

  • 00860008944894 ()
100011-04

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