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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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Cardio Flow Peripheral Guide Wire - 00850040691009

Cardio Flow Peripheral Guide Wire Guidewire, 325 CM
Cardio Flow, Inc.
GW1001
In Commercial Distribution

  • 00850040691023 ()
  • 00850040691009 ()
  • 00850040691016 ()

  • Guidewire Length: 325 Centimeter


  • Peripheral vascular guidewire, manual

CryoLab Aesthetics - 00850077006074

The CryoLab® Aesthetic device uses CryoConcepts’ design and technology to deliver a spray of Carbon Dioxide gas to treat topical cutaneous lesions. The intended use for the CryoLab® Aesthetics, is the surgical destruction of target tissue by extreme cold temperatures. Specifically, example lesions the device is intended to treat, based upon the literature, include skin tags, actinic keratosis, and seborrheic keratosis.
CRYOCONCEPTS, LP
700-1000
In Commercial Distribution

  • 00850077006074 ()
700-1000

  • Cryogenic spray, cutaneous

CryoLab Medical - 00850077006067

The CryoLab® Medical device uses CryoConcepts’ design and technology to deliver a spray of either Nitrous Oxide or Carbon Dioxide gas respectively to treat topical cutaneous lesions. The intended use for the CryoLab®, for both gases, is the surgical destruction of target tissue by extreme cold temperatures. Specifically, example lesions the device is intended to treat, based upon the literature, include molluscum contagiosum, skin tags, actinic keratosis, lentigo, verruca plana, verruca vulgaris, verruca plantaris, genital lesions, and seborrheic keratosis.
CRYOCONCEPTS, LP
200-1000
In Commercial Distribution

  • 00850077006067 ()
200-1000

  • Cryogenic spray, cutaneous

Avery Breathing Pacemaker System - 00850252006066

Digital Transmitter for the Avery Breathing Pacemaker System
Avery Biomedical Devices Inc
NeurostimulatorTransmitter Digital
In Commercial Distribution

  • 00850252006066 ()
Spirit

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system

Espion - 00850594007998

Profile System; with 23" Monitor on an Operating Room Arm and ColorBurst and Mini OLED with extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-1-23R-2-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007998 ()


  • Electroretinograph

Espion - 00850594007981

Profile System; with 23" Monitor on an Operating Room Arm and Mini OLED with extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-B-1-23R-N-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007981 ()


  • Electroretinograph

Espion - 00850594007974

Profile System; with 23" Monitor and ColorBurst and Mini OLED with extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-1-23F-2-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007974 ()


  • Electroretinograph

Espion - 00850594007967

Profile System; with 23" Monitor and Mini OLED with extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-B-1-23F-N-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007967 ()


  • Electroretinograph

Espion - 00850594007950

Profile System; with 32" Monitor and ColorBurst and Mini OLED with extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-G-1-32F-2-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007950 ()


  • Electroretinograph

Espion - 00850594007943

Profile System; with 32" Monitor and Mini OLED with extendable arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-B-1-32F-N-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007943 ()


  • Electroretinograph
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