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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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LED PRO SEAL® is intended for use as an enamel surface sealant around orthodontic brackets. LED PRO SEAL® can be illuminated or“revealed” on the tooth surface to check application using a Reliance Black Light or a simple portable (UV) light. Cures using a 468nm LED Light. 6ml bottle LED ProSeal
RELIANCE ORTHODONTIC PRODUCTS INC
LEDPRO
In Commercial Distribution

  • D798LEDPRO0 ()
LEDPRO

  • Dental pit/fissure sealant
AH Plus Jet Starter Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe delivery for homogeneous mixing of both pastes. With its supporting accessories (Mixing/Intraoral Tips, Mixing Pad and Organizer Tray) it can be classified as a convenience kit.
Dentsply De Trey GmbH
667005
In Commercial Distribution

  • D0106670051 ()

  • Weight: 15 Gram
  • Paste
667005

  • Endodontic filling/sealing material
The xTAG® Cystic Fibrosis Kit is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens
Luminex Molecular Diagnostics, Inc
I006C0068
Not in Commercial Distribution

  • 00840487100455 ()
I006C0068

  • Cystic fibrosis IVD, kit, multiplex
AH Plus Jet Refill Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe (D010606201180) delivery for homogeneous mixing of both pastes.
Dentsply De Trey GmbH
60620118
In Commercial Distribution

  • D010606201181 ()
  • D010606201180 ()

  • Weight: 15 Gram
  • Paste
60620118

  • Endodontic filling/sealing material
The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
AIR TECHNIQUES, INC.
D5000QB
In Commercial Distribution

  • D678D5000QB0 ()
  • D678D5000QB1 ()

  • Weight: 43 Pound
  • Height: 14 Inch
  • Length: 18 Inch
  • Width: 15.5 Inch


  • Radiography digital imaging scanner
The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
AIR TECHNIQUES, INC.
D5000Q
In Commercial Distribution

  • D678D5000Q0 ()
  • D678D5000Q1 ()

  • Weight: 43 Pound
  • Height: 14 Inch
  • Length: 18 Inch
  • Width: 15.5 Inch


  • Radiography digital imaging scanner
The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
AIR TECHNIQUES, INC.
D5000FB
In Commercial Distribution

  • D678D5000FB0 ()
  • D678D5000FB1 ()

  • Weight: 43 Pound
  • Height: 14 Inch
  • Length: 18 Inch
  • Width: 15.5 Inch


  • Radiography digital imaging scanner
The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
AIR TECHNIQUES, INC.
D5000F
In Commercial Distribution

  • D678D5000F0 ()
  • D678D5000F1 ()

  • Weight: 43 Pound
  • Height: 14 Inch
  • Length: 18 Inch
  • Width: 15.5 Inch


  • Radiography digital imaging scanner
CovoraTM is a sterile,single use device intended for use in partial thickness burns. CovoraTM is a soft, conformable, non-friable, absorbable matrix that provides an environment for the body’s natural healing process to occur
Acera Surgical Inc
COV1-10X12.5
In Commercial Distribution

  • 00854258006228 ()

  • Width: 12.5 Centimeter
  • Length: 10.0 Centimeter


  • Bioabsorbable wound dressing
CovoraTM is a sterile,single use device intended for use in partial thickness burns. CovoraTM is a soft, conformable, non-friable, absorbable matrix that provides an environment for the body’s natural healing process to occur
Acera Surgical Inc
COV1-7.5X7.5
In Commercial Distribution

  • 00854258006211 ()

  • Width: 7.5 Centimeter
  • Length: 7.5 Centimeter


  • Bioabsorbable wound dressing
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