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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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Light Jacket - 00860000230711

The Light Jacket® Attachable Light for Electrosurgical Pencil is offered as a sterile, one-time use disposable medical device for providing enhanced illumination of the surgical site when attached to an electrosurgical pencil.
PATHY MEDICAL, LLC
PM-LJ100
In Commercial Distribution

  • 00860000230704 ()
  • 00860000230711 ()


  • Operating room light

FreedomFlow Orbital Circumferential Atherectomy System - 00850040691085

FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 5Fr 150 cm, 3-Sphere
Cardio Flow, Inc.
H6004
In Commercial Distribution

  • 00850040691085 ()
  • 00850040691108 ()

  • Atherectomy Rotating Component Diameter: 1.5 Millimeter


  • Mechanical atherectomy system catheter, peripheral

FreedomFlow Orbital Circumferential Atherectomy System - 00850040691054

FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 6Fr 135 cm, 5-sphere
Cardio Flow, Inc.
H6002
In Commercial Distribution

  • 00850040691054 ()
  • 90850040691064 ()

  • Atherectomy Rotating Component Diameter: 2.0 Millimeter


  • Mechanical atherectomy system catheter, peripheral

FreedomFlow Orbital Circumferential Atherectomy System - 00850040691030

FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 5Fr 150 cm, 5-sphere
Cardio Flow, Inc.
H6001
In Commercial Distribution

  • 00850040691030 ()
  • 90850040691040 ()

  • Atherectomy Rotating Component Diameter: 1.5 Millimeter


  • Mechanical atherectomy system catheter, peripheral

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

Espion - 00850594007936

Profile System; with Xenon ColorDome on an Operating Room Arm and ColorBurst and Mini OLED with table stand & 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-CDXR-2-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007936 ()


  • Electroretinograph

Espion - 00850594007929

Profile System; with Non-Xenon ColorDome on an Operating Room Arm and ColorBurst and Mini OLED with table stand & 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-CDNR-2-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007929 ()


  • Electroretinograph

Espion - 00850594007912

Profile System; with Xenon ColorDome and ColorBurst and Mini OLED with table stand & 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-CDXS-2-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007912 ()


  • Electroretinograph

Espion - 00850594007905

Profile System; with Non-Xenon ColorDome and ColorBurst and Mini OLED with table stand & 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-CDNS-2-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007905 ()


  • Electroretinograph

Espion - 00850594007899

Profile System; with ColorBurst and Mini OLED with table stand & 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-NNNN-2-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007899 ()


  • Electroretinograph

Espion - 00850594007882

Profile System; with Xenon ColorDome on an Operating Room Arm and Mini OLED with table stand & 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-CDXR-N-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007882 ()


  • Electroretinograph

Espion - 00850594007875

Profile System; with Non-Xenon ColorDome on an Operating Room Arm and Mini OLED with table stand & 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-CDNR-N-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007875 ()


  • Electroretinograph

Espion - 00850594007868

Profile System; with Xenon ColorDome and Mini OLED with table stand & 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-CDXS-N-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007868 ()


  • Electroretinograph

Espion - 00850594007851

Profile System; with Non-Xenon ColorDome and Mini OLED with table stand & 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-CDNS-N-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007851 ()


  • Electroretinograph

Espion - 00850594007844

Profile System; with Xenon ColorDome 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-CDXR-2-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007844 ()


  • Electroretinograph

Espion - 00850594007837

Profile System; with Non-Xenon ColorDome 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-CDNR-2-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007837 ()


  • Electroretinograph

Espion - 00850594007820

Profile System; with Xenon ColorDome 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-CDXS-2-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007820 ()


  • Electroretinograph

Espion - 00850594007813

Profile System; with Non-Xenon ColorDome 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-CDNS-2-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007813 ()


  • Electroretinograph

Espion - 00850594007721

E3 system, 32-Bit Amplifier, All-in-One Touch Screen Computer with Espion S/W, Cart, and ColorBurst; 220V 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: D315-5-2-2
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007721 ()


  • Electroretinograph

Espion - 00850594007714

E3 system, 32-Bit Amplifier, All-in-One Touch Screen Computer with Espion S/W, Cart, and ColorBurst 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: D315-5-1-2
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007714 ()


  • Electroretinograph

Espion - 00850594007646

E3 System; with Xenon ColorDome on an OR Stand and ColorBurst and Mini OLED with table stand 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: D315-1-1-CDXRL-NN-2-T
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007646 ()


  • Electroretinograph

Espion - 00850594007615

E3 System; with Xenon ColorDome on an OR Stand and 23" Monitor 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: D315-1-1-CDXRL-23-N-N
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007615 ()


  • Electroretinograph

Espion - 00850594007608

E3 System; with Non-Xenon ColorDome and Mini OLED with table stand 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: D315-1-1-CDNSL-NN-N-T
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007608 ()


  • Electroretinograph

Espion - 00850594007585

E3 System; with Non-Xenon ColorDome and 23" Monitor and ColorBurst and Mini OLED with table stand 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: D315-1-1-CDNSL-23-2-T
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007585 ()


  • Electroretinograph

Espion - 00850594007578

E3 System; with Non-Xenon ColorDome and 23" Monitor and ColorBurst 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: D315-1-1-CDNSL-23-2-N
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007578 ()


  • Electroretinograph

Espion - 00850594007561

E3 System; with Non-Xenon ColorDome and 23" Monitor 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: D315-1-1-CDNSL-23-N-N
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007561 ()


  • Electroretinograph

Espion - 00850594007554

E3 System; with Xenon ColorDome and Mini OLED with table stand 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: D315-1-1-CDXSL-NN-N-T-D
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007554 ()


  • Electroretinograph

Espion - 00850594007547

E3 System; with Xenon ColorDome, ColorBurst and Mini OLED with table stand 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: D315-1-1-CDXSL-NN-2-T
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007547 ()


  • Electroretinograph

Espion - 00850594007530

E3 System; with Xenon ColorDome, 23" Monitor, ColorBurst and Mini OLED with table stand 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: D315-1-1-CDXSL-23-2-T
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007530 ()


  • Electroretinograph

Espion - 00850594007523

E3 System; with Xenon ColorDome and 23" Monitor 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: D315-1-1-CDXSL-23-N-N
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007523 ()


  • Electroretinograph

Espion - 00850594007516

E3 System; with Non-Xenon ColorDome on an OR Stand 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: D315-1-1-CDNRL-NN-N-N
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007516 ()


  • Electroretinograph

Espion - 00850594007509

E3 System; with Xenon ColorDome on an OR Stand 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: D315-1-1-CDXRL-NN-N-N
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007509 ()


  • Electroretinograph

Espion - 00850594007493

E3 System; with ColorBurst and Mini OLED with table stand 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: D315-1-1-NNNNN-NN-2-T
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007493 ()


  • Electroretinograph

Espion - 00850594007486

E3 System; with 23" Monitor and ColorBurst and Mini OLED with table stand 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: D315-1-1-NNNNN-23-2-T
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007486 ()


  • Electroretinograph

Espion - 00850594007479

E3 System; with 23" Monitor and Mini OLED with table stand 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: D315-1-1-NNNNN-23-N-T
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007479 ()


  • Electroretinograph

Espion - 00850594007462

Espion Profile Gold Pattern/VEP/ERG with Xenon ColorDome 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: D310MFCDXS
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007462 ()


  • Electroretinograph

Espion - 00850594007455

Espion Profile Gold Pattern/VEP/ERG with Non-Xenon ColorDome 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: D310MFCDNXS
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007455 ()


  • Electroretinograph

Espion - 00850594007448

Espion Profile Gold Pattern/VEP/ERG with ColorBurst and Xenon ColorDome 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: D310MFCBCDXS
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007448 ()


  • Electroretinograph

Espion - 00850594007431

Profile System; with 23" Monitor on an OR Arm and ColorBurst and Mini OLED with table stand 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-T
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007431 ()


  • Electroretinograph

Espion - 00850594007424

Profile System; with 23" Monitor on an OR Arm and Mini OLED with table stand 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-T
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007424 ()


  • Electroretinograph

Espion - 00850594007417

Profile System; with 23" Monitor and ColorBurst and Mini OLED with table stand 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-T
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007417 ()


  • Electroretinograph
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