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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3100A DISPOSABLES SHIP KIT (MR850 FLEX CIRCUIT)
VYAIRE MEDICAL, INC.
770630-103
In Commercial Distribution

  • 10190752200746 ()
770630-103

  • Breathing circuit condensate trap, single-use
  • Respiratory gas heating wire, adult
  • Microbial medical gas filter, single-use
  • Ventilator breathing circuit, single-use
The Raindrop Near Vision Inlay is a biocompatible hydrogel corneal inlay. It is designed to be implanted under a femtosecond laser flap onto the stromal bed of the cornea, centered over a light-constricted pupil. The Raindrop Near Vision Inlay reshapes the central region of the cornea to provide a zone of increased power for focusing on near objects, resulting in improvement in near vision. The Raindrop Near Vision Inlay is supplied steam sterilized and pre-loaded in its delivery device, the Inlay Inserter. It is for single-use only.
REVISION OPTICS, INC.
RD1-1
In Commercial Distribution

  • 10850394006013 ()
  • 20850394006010 ()

  • Diameter
RD1-1

  • Corneal inlay, aperture reducing
The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered. The Final Fit software has two major functions: 1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000 2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data)
NIDEK CO.,LTD.
1.12
In Commercial Distribution

  • 04987669100042 ()


  • Ophthalmic excimer laser system
The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered. The Final Fit software has two major functions: 1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000 2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data)
NIDEK CO.,LTD.
1.11US
In Commercial Distribution

  • 04987669100035 ()


  • Ophthalmic excimer laser system
The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered. The Final Fit software has two major functions: 1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000 2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data)
NIDEK CO.,LTD.
1.13
In Commercial Distribution

  • 04987669101346 ()


  • Ophthalmic excimer laser system
The 4170-3 is the Base Assembly component of the BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170 (BLU-U). The BLU-U Head Assembly (4170-1) is assembled for use only with the BLU-U Post Assembly (4170-2) and the BLU-U Base Assembly (4170-3). The BLU-U is a compact light source designed to provide a uniform distribution the blue light. The BLU-U Head Assembly (4170-1) is mounted on a Post Assembly (4170-2) and a Base Assembly (4170-3). The BLU-U has a built-in power output monitoring and diagnostic system, as well as a system timer used to set the light dose delivered to a patient.
DUSA PHARMACEUTICALS INC.
4170-3
In Commercial Distribution

  • M706417031 ()
4170-3

  • Skin photodynamic therapy/phototherapy lamp
The 4170-2 is the Post Assembly component of the BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170 (BLU-U). The BLU-U Head Assembly (4170-1) is assembled for use only with the BLU-U Post Assembly (4170-2) and the BLU-U Base Assembly (4170-3). The BLU-U is a compact light source designed to provide a uniform distribution the blue light. The BLU-U Head Assembly (4170-1) is mounted on a Post Assembly (4170-2) and a Base Assembly (4170-3). The BLU-U has a built-in power output monitoring and diagnostic system, as well as a system timer used to set the light dose delivered to a patient.
DUSA PHARMACEUTICALS INC.
4170-2
In Commercial Distribution

  • M706417021 ()
4170-2

  • Skin photodynamic therapy/phototherapy lamp
The 4170-1 is the Head Assembly component of the BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170 (BLU-U). The BLU-U Head Assembly (4170-1) is assembled for use only with the BLU-U Post Assembly (4170-2) and the BLU-U Base Assembly (4170-3). The BLU-U is a compact light source designed to provide a uniform distribution the blue light. The BLU-U Head Assembly (4170-1) is mounted on a Post Assembly (4170-2) and a Base Assembly (4170-3). The BLU-U has a built-in power output monitoring and diagnostic system, as well as a system timer used to set the light dose delivered to a patient.
DUSA PHARMACEUTICALS INC.
4170-1
In Commercial Distribution

  • M706417011 ()
4170-1

  • Skin photodynamic therapy/phototherapy lamp
The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with "Anderson" adapted models of monophasic and bi-phasic defibrillators.
HEART SYNC INC
Sterile-C100
Not in Commercial Distribution

  • 10868866000032 ()
  • 00868866000035 ()
Sterile-C100

  • Electrode conductive skin pad, single-use
The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with Zoll adapted models of monophasic and bi-phasic defibrillators.
HEART SYNC INC
Sterile-C100-Zoll
Not in Commercial Distribution

  • 10868866000025 ()
  • 00868866000028 ()
Sterile-C100-Zoll

  • Electrode conductive skin pad, single-use
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