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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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Universal Handle
KENSINGTON MEDICAL HOLDINGS LLC
FG-17
In Commercial Distribution

  • 00860000950091 ()


  • Device sterilization/disinfection container, reusable
Flash-Guard 12 with SS Clasp Lid, Universal Handle, and Instrument Rack
KENSINGTON MEDICAL HOLDINGS LLC
FG12-C
In Commercial Distribution

  • 00860000950084 ()


  • Device sterilization/disinfection container, reusable
Flash-Guard 23 with Stainless Steel Dome Lid, Universal Handle, and Instrument Rack
KENSINGTON MEDICAL HOLDINGS LLC
FG23-D
In Commercial Distribution

  • 00860000950077 ()


  • Device sterilization/disinfection container, reusable
Flash-Guard 20 with Poly Lid and Universal Handle
KENSINGTON MEDICAL HOLDINGS LLC
FG20-P
In Commercial Distribution

  • 00860000950060 ()


  • Device sterilization/disinfection container, reusable
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
CIRCA SCIENTIFIC, LLC
CS-100
In Commercial Distribution

  • 00860237000293 ()


  • Electrical-only medical device connection cable, reusable
Satisfyer Men Cooling 10oz
WESTRIDGE LABORATORIES INCORPORATED
Satisfyer Men Cooling 10oz
In Commercial Distribution

  • 40860230000878 ()
  • 00860230000870 ()
IDD11H06

  • Sexual lubricant
Satisfyer Men Warming 10oz
WESTRIDGE LABORATORIES INCORPORATED
Satisfyer Men Warming 10oz
In Commercial Distribution

  • 40860230000861 ()
  • 00860230000863 ()
IDD11H04

  • Sexual lubricant
Satisfyer Men Neutral 10oz
WESTRIDGE LABORATORIES INCORPORATED
Satisfyer Men Neutral 10oz
In Commercial Distribution

  • 40860230000854 ()
  • 00860230000856 ()
IDD11H07

  • Sexual lubricant
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