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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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THiA - 00754016215018

The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor.
Perimeter Medical Imaging AI, Inc.
PMI001OCT21
In Commercial Distribution

  • 00754016215018 ()
  • 10754016215015 ()
ASY-2000

  • Dermatological optical coherence tomography system

BD Difco™ Salmonella O Antiserum Poly A–I & Vi - 00382902226413

BD Difco™ Salmonella O Antiserum Poly A-I & Vi, 3 mL
BECTON, DICKINSON AND COMPANY
222641
In Commercial Distribution

  • 00382902226413 ()

  • Total Volume: 3 Milliliter
222641

  • Multiple Salmonella species antigen IVD, reagent

Enova Illumination - 00850025993579

Quantum Warm/PLT-175A LED Surgical Light
Enova Illumination, Inc.
80085
In Commercial Distribution

  • 00850025993579 ()


  • Head-worn lamp

Enova Illumination - 00850025993500

Quantum Cool/XLT-250A LED Surgical Light
Enova Illumination, Inc.
80086
In Commercial Distribution

  • 00850025993500 ()


  • Head-worn lamp

Unitron - 00698764444705

Quantum E S Met Dark Gray
Unitron Hearing Ltd
050-5576-43
In Commercial Distribution

  • 00698764444705 ()
050-5576-43

  • Air-conduction hearing aid, behind-the-ear

Unitron - 00698764444279

Quantum E HP Met Dark Gray
Unitron Hearing Ltd
050-5575-43
In Commercial Distribution

  • 00698764444279 ()
050-5575-43

  • Air-conduction hearing aid, behind-the-ear

Unitron - 00698764437332

Quantum Pro S Met Dark Gray
Unitron Hearing Ltd
050-5569-43
In Commercial Distribution

  • 00698764437332 ()
050-5569-43

  • Air-conduction hearing aid, behind-the-ear

Unitron - 00698764437059

Quantum Pro HP Met Dark Gray
Unitron Hearing Ltd
050-5568-43
In Commercial Distribution

  • 00698764437059 ()
050-5568-43

  • Air-conduction hearing aid, behind-the-ear

Unitron - 00698764395472

Quantum 6 HP Met Dark Gray
Unitron Hearing Ltd
050-5535-43
In Commercial Distribution

  • 00698764395472 ()
050-5535-43

  • Air-conduction hearing aid, behind-the-ear

Unitron - 00698764395199

Quantum 20 HP Met Dark Gray
Unitron Hearing Ltd
050-5533-43
In Commercial Distribution

  • 00698764395199 ()
050-5533-43

  • Air-conduction hearing aid, behind-the-ear
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