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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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PPS Glide - 00860010693148

No Description
PATIENT POSITIONING SYSTEMS, LLC
SPU Large
In Commercial Distribution

  • 00860010693148 ()


  • Inflatable patient transfer sliding mattress, single-use

PPS Glide - 00860010693131

Regular
PATIENT POSITIONING SYSTEMS, LLC
SPU Regular
In Commercial Distribution

  • 00860010693131 ()


  • Inflatable patient transfer sliding mattress, single-use

PPS Glide - 00860010693124

No Description
PATIENT POSITIONING SYSTEMS, LLC
Reusable Bariatric
In Commercial Distribution

  • 00860010693124 ()


  • Inflatable patient transfer sliding mattress, reusable

PPS Glide - 00860010693117

No Description
PATIENT POSITIONING SYSTEMS, LLC
Reusable Large
In Commercial Distribution

  • 00860010693117 ()


  • Inflatable patient transfer sliding mattress, reusable

PPS Glide - 00860010693100

Regular
PATIENT POSITIONING SYSTEMS, LLC
Reusable Regular
In Commercial Distribution

  • 00860010693100 ()


  • Inflatable patient transfer sliding mattress, reusable

Torch - 00860010685402

No Description
Voximetry, Inc.
V1.2
In Commercial Distribution

  • 00860010685402 ()


  • Nuclear medicine system workstation

Clearly - 00860010675700

Sequential clear aligner system to straighten teeth
Precision Align LLC
1
In Commercial Distribution

  • 00860010675700 ()


  • Orthodontic progressive aligner

Corix 70 - 00860010674406

Sistema diagnóstico de rayos X dental diseñado para fijación permanente en una ubicación con objeto de generar y controlar los haces de rayos X. Registra el patrón de absorción de los haces de rayos X utilizado para exámenes radiográficos dentales generales y rutinarios que implican el diagnóstico y tratamiento (p. ej., quirúrgico o intervencionista) de afecciones de las piezas dentales, mandíbula y cavidad bucal. El sensor se coloca fuera de la boca, con el propósito de visualizar toda el área de esta y mostrar las piezas dentales, tanto en la mandíbula superior como en la inferior. Los datos proceden de imágenes analógicas y que se digitalizan posteriormente o bien de imágenes digitales.
Coramex, S.A.
Corix 70 Plus USV
In Commercial Distribution

  • 00860010674406 ()


  • Stationary extraoral dental x-ray system, analogue

Fundus Photo - 00860010658109

Fundus Photo Digital Imaging System including hardware and/or software
Fundus Photo
CFD-440
In Commercial Distribution

  • 00860010658109 ()
CFD-440

  • Ophthalmic image analysis software
  • Multi-purpose digital medical camera lens, intraocular, visible/infrared light

AUVON - 00860010656334

No Description
Changsha Anxiang Medical Technology Co., LTD
TU3336
In Commercial Distribution

  • 00860010656334 ()


  • Analgesic transcutaneous electrical nerve stimulation system
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