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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™ 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
CU MTA1.1 110US/2060/G-QR/CU/D-3cell AEDA MT-S4-025
Aeda Healthcare Limited
2M01M060002 Rev.E / MT-S4-025
In Commercial Distribution

  • 04897079030108 ()


  • 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-A3-301
In Commercial Distribution

  • 04897079030085 ()


  • Alternating-pressure inflator
CU MTA1 110US/3060/D-QR/AEDA AERIA 10PRO
Aeda Healthcare Limited
1M01M060037 Rev.C / CU-A2-155
In Commercial Distribution

  • 04897079030061 ()


  • Alternating-pressure inflator
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