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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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Natus - 00382830048149

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

  • 00382830048149 ()


  • Electroencephalograph

Natus - 00382830047289

Natus Quantum II Breakout B
XLTEK
016868
In Commercial Distribution

  • 00382830047289 ()


  • Electroencephalograph

Natus - 00382830047272

Natus Quantum II Breakout Main
XLTEK
016867
In Commercial Distribution

  • 00382830047272 ()


  • Electroencephalograph

Natus - 00382830047265

Natus Quantum II Base Unit
XLTEK
016862
In Commercial Distribution

  • 00382830047265 ()


  • Electroencephalograph

NA - 00199150016679

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

  • 00199150016679 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00763000826024

CUSTOM PACK BB11U49R4 ADULT QUANTUM
MEDTRONIC, INC.
BB11U49R4
In Commercial Distribution

  • 00763000826024 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00763000774127

CUSTOM PACK BB11U49R3 ADULT QUANTUM
MEDTRONIC, INC.
BB11U49R3
In Commercial Distribution

  • 00763000774127 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00763000689445

CUSTOM PACK BB11V88R2 QUANTUM PACK
MEDTRONIC, INC.
BB11V88R2
In Commercial Distribution

  • 00763000689445 ()


  • Cardiopulmonary bypass system blood tubing set

S-Series OCT - 00754016215049

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

Specimen Immobilizer - 00754016215025

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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