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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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LED Light Therapy. Uses 1820 LED. Purpose is to relieve minor joint or muscle pain using Infrared Light or Combo Red/Infrared Light to provide a feeling of General Wellness.
Medtek Lighting Corporation
Regen
In Commercial Distribution

  • B3437000A3 ()


  • Blue/red/infrared phototherapy lamp
Tether Tension Indicator
Highridge Medical, LLC
240H6004
In Commercial Distribution

  • 03662663080842 ()
240H6004

  • Anterior spinal tethering system tether
Tether Reel Tensioner
Highridge Medical, LLC
240H6003
In Commercial Distribution

  • 03662663080835 ()
240H6003

  • Anterior spinal tethering system tether
No Description
ACESO DENTAL LABORATORY COMPANY LIMITED
120
In Commercial Distribution

  • 08936214221219 ()
  • 08936214221202 ()


  • Partial denture
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic
No Description
Modern Dental Laboratory (DG) Co., Ltd.
132
In Commercial Distribution

  • 06972677871334 ()
  • 06972677871327 ()


  • Partial denture
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423738
Not in Commercial Distribution

  • 00815381020482 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423883
In Commercial Distribution

  • 00815381020239 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
The UroShield driver is an electronic unit intended to drive an accessory (Ultrasonic Actuator) that creates surface acoustic waves on Urinary catheter to prevent bacterial adhesion and minimized risk of CAUTI (Catheter Associated Urinary Tract Infections).
NANOVIBRONIX INC.
3.0
In Commercial Distribution

  • 07290103420277 ()
10-800-0003

  • Urinary catheter ultrasonic bacterial adhesion inhibition system
No Description
ACESO DENTAL LABORATORY COMPANY LIMITED
326
In Commercial Distribution

  • 08936214223275 ()
  • 08936214223268 ()


  • Partial denture
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic
  • Custom-made dental crown, ceramic
  • Dental bridge, ceramic
  • Ceramic dental inlay
  • Dental veneer, professional
No Description
ACESO DENTAL LABORATORY COMPANY LIMITED
132
In Commercial Distribution

  • 08936214221332 ()
  • 08936214221325 ()


  • Partial denture
  • Custom-made dental crown, metal/polymer
  • Custom-made dental crown, polymer
  • Dental bridge, metal-polymer
  • Dental bridge, polymer
  • Dental veneer, professional
  • Resin dental inlay
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