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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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Single-Use Retraction Sheath
CEEK WOMEN'S HEALTH
VS000
In Commercial Distribution

  • 00860000270403 ()
  • 10860000270400 ()


  • Vaginal speculum, single-use
Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina segment of the eye to be evaluated under non-mydriatic conditions. Verily Numetric Retinal Camera is indicated for in-vivo viewing of the posterior segment of the eye. The images are intended for use as an aid to clinicians in the evaluation, diagnosis, and documentation of ocular health.
VERILY LIFE SCIENCES LLC
VNRC -101
In Commercial Distribution

  • 00860000249584 ()


  • Ophthalmic fundus camera
VirtuOst VFA uses sagittal sections from a spine-containing CT scan, with or without contrast enhancement, to visualize and measure vertebral deformities, classify the type and grade of any existing vertebral fracture, and from this identify patients at high risk of a future osteoporosis-related fracture. This information can be interpreted by a physician to diagnose existing vertebral fractures and to manage patients for osteoporosis.
O N DIAGNOSTICS LLC
A
In Commercial Distribution

  • 00860000233118 ()


  • Radiology DICOM image processing application software
VirtuOst uses data from computed tomography scans to estimate bone mineral density, bone strength, and a load-to-strength ratio. This information can be used by a physician to assess fracture risk, identify osteoporosis, and monitor therapy. For pediatric patients, VirtuOst provides these estimates without any classifications and should be used only when the benefit of obtaining these estimates outweighs the risk of radiation.
O N DIAGNOSTICS LLC
A
In Commercial Distribution

  • 00860000233101 ()


  • Radiology DICOM image processing application software
The Light JacketĀ® 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
Satisfaite vaginal moisturizer and personal lubricant is a non-sterile, water-based, white to off-white, non-irritating, non-greasy, non-staining low volume gel delivered in a single use disposable applicator for vaginal dryness. The applicator provides convenience and provides for less mess during application. Satisfaite is intended for ongoing use, not exclusively for use during intimate sexual activity. Satisfaite contains ingredients commonly used in other products for intravaginal use sold as medical devices and cosmetics. All ingredients used are approved high quality pharmaceutical grade, and considered "generally recognized as safe for their intended use" by the FDA. The quantitative formulation is considered confidential commercial information.
FEMMEPHARMA CONSUMER HEALTHCARE LLC
01
In Commercial Distribution

  • 00860000221511 ()
01

  • Sexual lubricant
No Description
Rst- Sanexas
55105
In Commercial Distribution

  • 00860000214056 ()


  • Blue/red/infrared phototherapy lamp
No Description
Rst- Sanexas
RST-SANEXAS PT
In Commercial Distribution

  • 00860000214049 ()


  • Transcranial electrical stimulation system, pulsed-current
No Description
Rst- Sanexas
RST-SANEXAS Basic
In Commercial Distribution

  • 00860000214032 ()


  • Transcranial electrical stimulation system, pulsed-current
No Description
Rst- Sanexas
55105
In Commercial Distribution

  • 00860000214025 ()
  • 10860000214022 ()


  • Blue/red/infrared phototherapy lamp
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