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
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 TTC Colonic Balloon Dilator
COOK INCORPORATED
G22997
In Commercial Distribution

  • 00827002229976 ()
QDC-20X5.5

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Esophageal Balloon Dilator
COOK INCORPORATED
G22774
Not in Commercial Distribution

  • 00827002227743 ()
QD-18X8-E

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Esophageal Balloon Dilator
COOK INCORPORATED
G22773
Not in Commercial Distribution

  • 00827002227736 ()
QD-16X8-E

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Esophageal Balloon Dilator
COOK INCORPORATED
G22772
Not in Commercial Distribution

  • 00827002227729 ()
QD-14X8-E

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Biliary Balloon Dilator
COOK INCORPORATED
G22767
In Commercial Distribution

  • 00827002227675 ()
QBD-10X3-E

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Biliary Balloon Dilator
COOK INCORPORATED
G22766
In Commercial Distribution

  • 00827002227668 ()
QBD-8X3-E

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Biliary Balloon Dilator
COOK INCORPORATED
G22765
In Commercial Distribution

  • 00827002227651 ()
QBD-6X3-E

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Biliary Balloon Dilator
COOK INCORPORATED
G22657
In Commercial Distribution

  • 00827002226579 ()
QBD-10X3

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Biliary Balloon Dilator
COOK INCORPORATED
G22656
In Commercial Distribution

  • 00827002226562 ()
QBD-8X3

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Biliary Balloon Dilator
COOK INCORPORATED
G22655
In Commercial Distribution

  • 00827002226555 ()
QBD-6X3

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Biliary Balloon Dilator
COOK INCORPORATED
G22654
In Commercial Distribution

  • 00827002226548 ()
QBD-4X3

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Pyloric Balloon Dilator
COOK INCORPORATED
G22552
Not in Commercial Distribution

  • 00827002225527 ()
QDP-18X5.5

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Colonic Balloon Dilator
COOK INCORPORATED
G22541
In Commercial Distribution

  • 00827002225411 ()
QDC-10X5.5

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Colonic Balloon Dilator
COOK INCORPORATED
G22540
In Commercial Distribution

  • 00827002225404 ()
QDC-8X5.5

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Quantum TTC Esophageal Balloon Dilator
COOK INCORPORATED
G31511
In Commercial Distribution

  • 00827002315112 ()
QD-20X8

  • 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
Quantum Breakout DC Input Cable
XLTEK
013930
In Commercial Distribution

  • 00382830016445 ()


  • Electrical-only medical device connection cable, reusable
Natus Quantum Oximeter Adapter Cable
XLTEK
013931
In Commercial Distribution

  • 00382830016438 ()


  • Electroencephalograph
Natus Quantum Pin Box 193-256
XLTEK
014165
In Commercial Distribution

  • 00382830016377 ()


  • Electroencephalograph
Natus Quantum Pin Box 129-192
XLTEK
014164
In Commercial Distribution

  • 00382830016360 ()


  • Electroencephalograph
Natus Quantum Pin Box 65-128
XLTEK
014163
In Commercial Distribution

  • 00382830016353 ()


  • Electroencephalograph
Natus Quantum Pin Box 1-64
XLTEK
014162
In Commercial Distribution

  • 00382830016346 ()


  • Electroencephalograph
Quantum (Phase II) 64-channel Breakout
XLTEK
024229
In Commercial Distribution

  • 00382830048149 ()


  • Electroencephalograph
Natus Quantum II Breakout B
XLTEK
016868
In Commercial Distribution

  • 00382830047289 ()


  • Electroencephalograph
Natus Quantum II Breakout Main
XLTEK
016867
In Commercial Distribution

  • 00382830047272 ()


  • Electroencephalograph
Natus Quantum II Base Unit
XLTEK
016862
In Commercial Distribution

  • 00382830047265 ()


  • Electroencephalograph
CUSTOM PACK BB11V88R8 QUANTUM PACK
MEDTRONIC, INC.
BB11V88R8
In Commercial Distribution

  • 00199150016679 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11U49R4 ADULT QUANTUM
MEDTRONIC, INC.
BB11U49R4
In Commercial Distribution

  • 00763000826024 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11U49R3 ADULT QUANTUM
MEDTRONIC, INC.
BB11U49R3
In Commercial Distribution

  • 00763000774127 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK BB11V88R2 QUANTUM PACK
MEDTRONIC, INC.
BB11V88R2
In Commercial Distribution

  • 00763000689445 ()


  • Cardiopulmonary bypass system blood tubing set
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
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, 3 mL
BECTON, DICKINSON AND COMPANY
222641
In Commercial Distribution

  • 00382902226413 ()

  • Total Volume: 3 Milliliter
222641

  • Multiple Salmonella species antigen IVD, reagent
Quantum Warm/PLT-175A LED Surgical Light
Enova Illumination, Inc.
80085
In Commercial Distribution

  • 00850025993579 ()


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

  • 00850025993500 ()


  • Head-worn lamp
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
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