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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TF XG5 -> XG3D, 3D upgrade kit for a 2D device
SIRONA Dental Systems GmbH
6331321
In Commercial Distribution

  • E27663313210 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
TF XG Plus -> XG3D, 3D upgrade kit for a 2D device
SIRONA Dental Systems GmbH
6331313
In Commercial Distribution

  • E27663313130 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
31-115 TMT Tourniquet 1 EA L01-003 3x1 blank polypropylene 1 EA L81-000 MARCH Bag Hang Tag 1 EA 89-115-BL TMT Holster Pouch 1 EA
Safeguard US Operating, LLC
1
In Commercial Distribution

  • M689SDRTQH010 ()
SDR TQH TMT

  • Tourniquet cuff, single-use
TF XG plus TSA/Ceph -> XG3D, 3D upgrade kit for a 2D device
SIRONA Dental Systems GmbH
6368836
In Commercial Distribution

  • E27663688360 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Palodent Plus System Trial Kit
DENTSPLY INTERNATIONAL INC.
659880V
Not in Commercial Distribution

  • D002659880V1 ()

  • 1x Universal Ring, 10x Matrices (5.5mm), 10x Medium Wedges, 10x Medium WedgeGuards, 5x SureFil® SDR® Compula® Tips (Universal shade), 1x Forceps, 1x Pin Tweezers
659880V

  • Dental wedge, single-use
  • Dental matrix band, single-use
  • Rubber dam clamp forceps
  • Dental matrix band tensioner
  • Dental dressing forceps, reusable
Palodent Plus Trial Kit
DENTSPLY INTERNATIONAL INC.
659880
In Commercial Distribution

  • D0026598801 ()

  • 1x Universal Ring, 10x Matrices (5.5mm), 10x Medium Wedges, 10x Medium WedgeGuards, 5x SureFil® SDR® Compula® Tips (Universal shade), 1x Forceps, 1x Pin Tweezers
659880

  • Dental matrix band, single-use
  • Dental wedge, single-use
  • Rubber dam clamp forceps
  • Dental matrix band tensioner
  • Dental dressing forceps, reusable
ANTIFUNGAL QC LEVEL 1
UTAK LABORATORIES, INC.
ANTIF QC 1 V2 LP F TF
In Commercial Distribution

  • B800ANTIFQC1V2LPFTF5 ()
  • B800ANTIFQC1V2LPFTF0 ()

  • Total Volume: 1 Milliliter
ANTIF QC 1 V2 LP F TF

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTIFUNGAL QC LEVEL 3
UTAK LABORATORIES, INC.
ANTIF QC 3 V2 LP F TF
In Commercial Distribution

  • B800ANTIFQC3V2LPFTF5 ()
  • B800ANTIFQC3V2LPFTF0 ()

  • Total Volume: 1 Milliliter
ANTIF QC 3 V2 LP F TF

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTIFUNGAL QC LEVEL 2
UTAK LABORATORIES, INC.
ANTIF QC 2 V2 LP F TF
In Commercial Distribution

  • B800ANTIFQC2V2LPFTF5 ()
  • B800ANTIFQC2V2LPFTF0 ()

  • Total Volume: 1 Milliliter
ANTIF QC 2 V2 LP F TF

  • Multiple-therapy therapeutic drug monitoring IVD, control
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