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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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iNterra™ VLC Curing Unit 120V
DENTSPLY INTERNATIONAL INC.
61D100
Not in Commercial Distribution

  • D00261D1000 ()

  • Interra VLC Curing Unit (120v), 1 Power Cord, 3 Replacement Bulbs, 1 Pair of Gloves
61D100

  • Custom-made mouthguard
iNterra™ iNoffice Nightguard Refill Package, Large Arch, 6
DENTSPLY INTERNATIONAL INC.
61D040
Not in Commercial Distribution

  • D00261D04062 ()
  • D00261D0401 ()
  • D00261D0400 ()

  • 6 iNterra™ Nightguard Arches, Large Arch
61D040

  • Custom-made mouthguard
iNterra™ iNoffice Nightguard Refill Package, Medium Arch, 6
DENTSPLY INTERNATIONAL INC.
61D030
Not in Commercial Distribution

  • D00261D03062 ()
  • D00261D0301 ()
  • D00261D0300 ()

  • 6 iNterra™ Nightguard Arches, Medium Arch
61D030

  • Custom-made mouthguard
iNterra™ iNoffice Nightguard Refill Package, Small Arch, 6
DENTSPLY INTERNATIONAL INC.
61D020
Not in Commercial Distribution

  • D00261D02062 ()
  • D00261D0201 ()
  • D00261D0200 ()

  • 6 iNterra™ Nightguard Arches, Small Arch
61D020

  • Custom-made mouthguard
iNterra™ iNoffice Nightguard Starter Kit
DENTSPLY INTERNATIONAL INC.
61D010
Not in Commercial Distribution

  • D00261D01062 ()
  • D00261D0101 ()

  • Total Volume: 50 Milliliter
  • 1 Small Arch, 2 Medium Arches, 1 Large Arch, 1 Cartridge Regisil® Rigid Super Fast Set Material (50mL), 6 Mixing Tips
61D010

  • Custom-made mouthguard
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MH-525
Not in Commercial Distribution

  • 04953170055546 ()
  • 84953170055542 ()


  • Ultrasound endoscope balloon, Hevea-latex
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MH-303
Not in Commercial Distribution

  • 04953170053870 ()
  • 84953170053876 ()


  • Ultrasound endoscope balloon, Hevea-latex
VIDEO LARYNGOSTROBOSCOPE (HD) (USED)
PENTAX OF AMERICA, INC.
VLS-1590STI
In Commercial Distribution

  • 04961333240395 ()


  • Laryngostroboscope
VIDEO LARYNGOSTROBOSCOPE (90 SERIES) (USED)
PENTAX OF AMERICA, INC.
VLS-1190STK
In Commercial Distribution

  • 04961333240388 ()


  • Laryngostroboscope
VIDEO LARYNGOSTROBOSCOPE (SLIM) (USED)
PENTAX OF AMERICA, INC.
VLS-1070STK
In Commercial Distribution

  • 04961333240371 ()


  • Laryngostroboscope
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