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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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Capillary Tubes
DRUMMOND SCIENTIFIC COMPANY
1-000-7500-HC
In Commercial Distribution

  • 00860001024012 ()
  • 10860001024019 ()
1-000-7500-HC/5

  • Capillary blood collection tube IVD, ammonium heparin
Capillary Tubes
DRUMMOND SCIENTIFIC COMPANY
1-000-7500-C
In Commercial Distribution

  • 00860001024005 ()
  • 10860001024002 ()
1-000-7500-C/5

  • Capillary blood collection tube IVD, no additive
No Description
Athelas, Inc.
850-00001-00
In Commercial Distribution

  • 00860001013238 ()


  • Haematological cell analyser IVD
No Description
Athelas, Inc.
850-00002-00
In Commercial Distribution

  • 00860001013221 ()
  • 00860001013214 ()


  • Laboratory analyser cuvette IVD, single-use
Medication management system
ONE WORLD DESIGN AND MANUFACTURING GROUP LTD
1
In Commercial Distribution

  • 00860000925907 ()


  • Personal pill dose dispenser, electric
System, Imaging, Pulsed Echo, Ultrasonic
Healcerion Co., Ltd.
300L
Not in Commercial Distribution

  • 00860000879842 ()
300L

  • Extracorporeal ultrasound imaging transducer, mounted
System, Imaging, Pulsed Doppler, Ultrasonic
Healcerion Co., Ltd.
300L
Not in Commercial Distribution

  • 00860000879835 ()
300L

  • Extracorporeal ultrasound imaging transducer, mounted
No Description
INTOUCH TECHNOLOGIES, INC.
InTouch Lite 4 with Boom
In Commercial Distribution

  • 00860000825818 ()


  • Video consultation telemedicine system
An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It is intended for use with a dedicated ultrasound system with dedicated software installed. This is a reusable device.
LINKQUEST INC.
LQ-E8C1
In Commercial Distribution

  • 00860000784832 ()


  • Rectal/vaginal ultrasound imaging transducer
A sterilization indicator designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. This is a single-use device.
INDILAB INC.
IND400S
Not in Commercial Distribution

  • 00860000763615 ()
  • 00860000763608 ()

  • Length: 4 Inch
IND400S

  • Chemical/physical sterilization process indicator
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