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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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JUSTI- PAKTO POWDER - D772ATI280003TO0

JUSTI- PAKTO POWDER 4 OZ TRANS. OVER
AMERICAN TOOTH INDUSTRIES
070-28-0003/TO
In Commercial Distribution

  • D772ATI280003TO0 ()


  • Dental acrylic resin

JUSTI- PAKTO POWDER - D772ATI280002TO0

JUSTI- PAKTO POWDER 1 OZ TRANS. OVER
AMERICAN TOOTH INDUSTRIES
070-28-0002/TO
In Commercial Distribution

  • D772ATI280002TO0 ()


  • Dental acrylic resin

PYROPLAST POWDER - D772ATI100404TO0

PYROPLAST POWDER 4 OZ SHADE TRANS. OVER
AMERICAN TOOTH INDUSTRIES
070-10-0404/TO
In Commercial Distribution

  • D772ATI100404TO0 ()


  • Dental acrylic resin

PYROPLAST POWDER - D772ATI100401TO0

PYROPLAST POWDER 1 OZ SHADE TRANS. OVER
AMERICAN TOOTH INDUSTRIES
070-10-0401/TO
In Commercial Distribution

  • D772ATI100401TO0 ()


  • Dental acrylic resin

Samsung Sleep Apnea Feature (Android OS) - 08806094936889

The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094936889 ()


  • Patient general health self-management software

EyeCaster - 00860012447121

Slit-Lamp imaging for HS BQ900
Innovations Lightx Inc
BSI-14-HS-BQ900
In Commercial Distribution

  • 00860012447121 ()


  • Smartphone camera ophthalmic imaging lens

EyeCaster - 00860012447145

Universal slit-lamp imaging device.
Innovations Lightx Inc
BSI-14-UN
In Commercial Distribution

  • 00860012447145 ()


  • Smartphone camera ophthalmic imaging lens

EyeCaster - 00860012447138

Slit-Lamp imaging for HS BP900
Innovations Lightx Inc
BSI-14-HS-BP900
In Commercial Distribution

  • 00860012447138 ()


  • Smartphone camera ophthalmic imaging lens

myPKFiT for Healthcare Professionals - 00850025688819

Web application used by Healthcare Professionals to generate dose calculations
Takeda Pharmaceuticals U.S.A., Inc.
V3
In Commercial Distribution

  • 00850025688819 ()


  • Home pharmaceutical management support software

WaveForm™ TO - 10889981234768

Interbody, 9mm x 24mm x 12mm, 15 Deg, 3D
Seaspine Orthopedics Corporation
WO1-924125
In Commercial Distribution

  • 10889981234768 ()
WO1-924125

  • Metallic spinal interbody fusion cage
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