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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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Organ Care System - B00953983

OCS Data Card
TRANSMEDICS, INC.
1404
In Commercial Distribution

  • B00953985 ()
  • B00953983 ()

  • Height: 0.08 Inch
  • Width: 1.25 Inch
  • Length: 1 Inch
1404

  • Data storage card

Organ Care System - B00953973

OCS Data Card
TRANSMEDICS, INC.
1404
In Commercial Distribution

  • B00953975 ()
  • B00953973 ()

  • Length: 1 Inch
  • Width: 1.25 Inch
  • Height: 0.08 Inch
1404

  • Data storage card

iNterra™ iNoffice Nightguard - D00261D1000

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 - D00261D0401

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 - D00261D0301

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 - D00261D0201

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 - D00261D0101

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

SML - D854620651

The POD
SELANE PRODUCTS, INC.
62065
In Commercial Distribution

  • D854620651 ()


  • Custom-made mouthguard

WARMER, SINGLE CHAMBER - SWC2430364B

Overall size 30”W x 26.5”D x 36”T. 8.63 Cubic ft. storage Chamber I.D. 26”W x 23”D x 25”T. Temperature Range: 90-160 F Accuracy +/- 2 degrees F of set point 2 Adjustable shelves Digital control Stainless steel door Audible and visual over-temp alarm Keyed temperature lock Door lock Data logger Foot levelers 4" base Electrical: 120V, 7.5 Amp, 50/60 Hz .35 kw/hr, 1195 btu/hr UL/CUL listed FDA Regist
M.A.C. MEDICAL INC.
SWC243036-4B
In Commercial Distribution

  • SWC2430364B ()
SWC243036-4B

  • Blanket warming cabinet, dry-heat

JEDMED - M63370X99600

VIDEO ADAPTOR F=22MM F/STROBO II
JEDMED INSTRUMENT COMPANY
70X9960
In Commercial Distribution

  • M63370X99600 ()
70X9960

  • Laryngostroboscope
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