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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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StatPACS is a software based PACS product, intended to be used by radiologists, technologists and clinicians to operate on specified off the shelf hardware that will provide a teleradiology and PACS solution for hospitals/clinics and remote site use. The StatPACS software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis.
NUCLEUSHEALTH, LLC
1000
In Commercial Distribution

  • 00860257001102 ()


  • Diagnostic imaging telemedicine system
Kohli Urinary Drainage Catheter, 16 Fr, Silicone
NELLIE MEDICAL, LLC
20-100
In Commercial Distribution

  • 00860239001328 ()
  • 00860239001311 ()
  • 00860239001304 ()

  • Catheter Length: 440 Millimeter
  • Catheter Gauge: 16 French
20-100

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
No Description
LUMA THERAPEUTICS, INC.
CAT0581
In Commercial Distribution

  • 00860228002107 ()


  • Light-energy skin surface treatment system applicator
Ketone Test Strips - 40 pack
Ketobm LLC
KS-01
In Commercial Distribution

  • 00860182000645 ()


  • Ketone (acetoacetate) IVD, reagent
FUSION-DOE Light System
Dentlight Inc.
7700512
In Commercial Distribution

  • 00860179001075 ()
7700512

  • Oral lesion examination light
The System 83 RevolveĀ® Endoscope Washer/Disinfector is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes utilizing a detergent and FDA cleared high-level disinfectant validated by Wassenburg Medical. The System 83 RevolveĀ® utilizes a processing chamber and the immersion method to perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high-level disinfected endoscope. The System 83 RevolveĀ® is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the channels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocess
Wassenburg Medical, Inc.
System 83 Revolve
In Commercial Distribution

  • 00860010835241 ()


  • Endoscope washer-disinfector (chemical)
Mandible And Maxilla Model - 2 Piece
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801697 ()
MAPMANI2P

  • Custom-made organ/bone anatomy model
Screw metal sleeve
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801680 ()
Q-SPTS

  • Custom-made orthopaedic/craniofacial surgical guide
Slot metal sleeve
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801673 ()
Q-SPCS

  • Custom-made orthopaedic/craniofacial surgical guide
Drill metal sleeve
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801666 ()
Q-SPBS

  • Custom-made orthopaedic/craniofacial surgical guide
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