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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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Quantum TTC Esophageal Balloon Dilator
COOK INCORPORATED
G22313
In Commercial Distribution

  • 00827002223134 ()
QD-18X8

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Esophageal Balloon Dilator
COOK INCORPORATED
G22312
In Commercial Distribution

  • 00827002223127 ()
QD-16X8

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Esophageal Balloon Dilator
COOK INCORPORATED
G22311
In Commercial Distribution

  • 00827002223110 ()
QD-14X8

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Esophageal Balloon Dilator
COOK INCORPORATED
G22310
In Commercial Distribution

  • 00827002223103 ()
QD-12X8

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Esophageal Balloon Dilator
COOK INCORPORATED
G22309
In Commercial Distribution

  • 00827002223097 ()
QD-10X8

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Esophageal Balloon Dilator
COOK INCORPORATED
G22308
In Commercial Distribution

  • 00827002223080 ()
QD-8X8

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Esophageal Balloon Dilator
COOK INCORPORATED
G22307
In Commercial Distribution

  • 00827002223073 ()
QD-6X8

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
QUANTUM QT-750 TABLE F/ STD-Q
CARESTREAM HEALTH, INC.
QT-750
In Commercial Distribution

  • 60889974000214 ()
AB6459

  • Basic diagnostic x-ray system table, powered
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

  • 00754016215049 ()
  • 10754016215046 ()
ASY-2000

  • Dermatological optical coherence tomography system
The OTIS 2.1 system includes a single-use specimen container, the Consumable Set, that facilitates tissue imaging. The consumable set consists of a Specimen Tray and Specimen Lid. The Specimen Tray engages with the device to initiate scanning and the Specimen Lid facilitates engaging vacuum to enable vacuum assisted specimen positioning during image acquisition.
Perimeter Medical Imaging AI, Inc.
PMI010CON21
In Commercial Distribution

  • 20754016215029 ()
  • 00754016215025 ()
  • 00754016215032 ()
ASY-2600

  • Dermatological optical coherence tomography system
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