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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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FACE MASKS
Premium Plus International Limited
2288TL
In Commercial Distribution

  • D8382288TL8 ()
  • D8382288TL2 ()
  • D8382288TL0 ()


  • Surgical/medical face mask, single-use
FACE MASKS
Premium Plus International Limited
2288TB
In Commercial Distribution

  • D8382288TB8 ()
  • D8382288TB2 ()
  • D8382288TB0 ()


  • Surgical/medical face mask, single-use
Disposable Napkin Holders
Premium Plus International Limited
2209
In Commercial Distribution

  • D83822098 ()
  • D83822094 ()
  • D83822090 ()


  • Towel clamp, reusable
Toothbrush holder
Premium Plus International Limited
2005
In Commercial Distribution

  • D83820058 ()
  • D83820052 ()


  • Specimen container mailer, non-insulated
Disposable Barrier Sleeves
Premium Plus International Limited
199-2
In Commercial Distribution

  • D83819928 ()
  • D83819922 ()
  • D83819920 ()


  • Instrument/equipment drape, single-use, non-sterile
Disposable Barrier Sleeves
Premium Plus International Limited
199-0
In Commercial Distribution

  • D83819908 ()
  • D83819902 ()
  • D83819900 ()


  • Instrument/equipment drape, single-use, non-sterile
A thermoplastic material designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device.
ALL DENTAL PRODX
144700
In Commercial Distribution

  • D8161447001 ()
  • D8161447000 ()


  • Composite dental impression material
No Description
MARIE REIKO INC
Endo Dental Spray
In Commercial Distribution

  • D872AB200109 ()
  • D872AB20121 ()


  • Cryogenic spray, dental
FiXcision is an EO‐sterilized, single use, multi‐part, manual cutting instrument for use during anal fistula surgery in coloproctology. FiXcision enables circumferential tissue removal for the treatment of simple anal fistulae.
AMI Agency for Medical Innovations GmbH
FIX2001
In Commercial Distribution

  • EAMIFIX20011 ()
  • EAMIFIX20010 ()
FIX2001

  • Anal fistula circular cutter
No Description
AMI Agency for Medical Innovations GmbH
EVI1011
Not in Commercial Distribution

  • EAMIEVI10111 ()
  • EAMIEVI10110 ()

  • Outer Diameter: 5 Millimeter
  • Length: 45 Millimeter
EVI1011

  • Endoscopic electrosurgical electrode, monopolar, single-use
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