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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
insulated forceps, 9" (23.0 cm)
NOVO SURGICAL, INC.
NSB50531-1
In Commercial Distribution

  • 00842331190889 ()


  • Open-surgery electrosurgical electrode, monopolar, reusable
CU Aeria Pro Digital 5 step Bariatric with Power cord  US  110V
Aeda Healthcare Limited
2M01M060022 Rev.B / MT-C4-231
In Commercial Distribution

  • 04897079030184 ()


  • Alternating-pressure inflator
This medical device is an Air Pump, and also named as Alternating Control Unit or Alternating-Pressure Pump, it is always used with an Air Mattress together, and combines into a Mattress System (Alternating Air Pressure Mattress), its function is controlling the Air Mattress to be inflated and deflated alternatively with a setting cycle time.
Aeda Healthcare Limited
MT-A3-300
In Commercial Distribution

  • 04897079030160 ()
  • 04897079030146 ()


  • Alternating-pressure inflator
CU MTA1.1 110US/2060/G-QR/CU/D-3cell MT-S4-025 W/packing
Aeda Healthcare Limited
1M01M060059 Rev.E / MT-S4-025
In Commercial Distribution

  • 04897079030153 ()
  • 04897079030139 ()


  • Alternating-pressure inflator
CU 201S 110US/3060/QR/AERIA8 MT-S4-035 with inner box
Aeda Healthcare Limited
2M01M060012 Rev.C / MT-S4-035
In Commercial Distribution

  • 04897079030122 ()


  • Alternating-pressure inflator
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