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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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Fiberoptics Technology Inc - 00862658000302

LO-50 LED Fiber Optic Light Source
FIBEROPTICS TECHNOLOGY, INC.
LO-50
In Commercial Distribution

  • 00862658000302 ()


  • Operating room light

PolypVac® - 00862519000328

No Description
LAURIMED, LLC
4.0mm Microdebrider
In Commercial Distribution

  • 00862519000328 ()
  • 00862519000335 ()
FG-000017

  • ENT shaver system handpiece

PolypVac® - 00862519000304

No Description
LAURIMED, LLC
3.3mm Microdebrider
In Commercial Distribution

  • 00862519000304 ()
  • 00862519000311 ()
FG-000016

  • ENT shaver system handpiece

NuSmile NeoMTA - 00862487000320

Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
NUSMILE, LTD.
NMTA 7.0
Not in Commercial Distribution

  • 00862487000320 ()

  • Weight: 7.0 Gram
None

  • Glass ionomer dental cement
  • Endodontic filling/sealing material

NuSmile NeoMTA - 00862487000313

Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
NUSMILE, LTD.
NMTA2.5
In Commercial Distribution

  • 00862487000313 ()

  • Weight: 2.5 Gram
None

  • Hygroscopic dental cement

NuSmile NeoMTA - 00862487000306

Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
NUSMILE, LTD.
NMTA0.5
In Commercial Distribution

  • 00862487000306 ()

  • Weight: 0.5 Gram
None

  • Hygroscopic dental cement

PADnet - 00862467000302

No Description
Collaborative Care Diagnostics LLC
2.0
In Commercial Distribution

  • 00862467000302 ()


  • Limb plethysmograph

Boston Keratoprosthesis Lucia Type I - 00862395000214

Boston Keratoprosthesis Lucia Type 1 Aphakia with anodized Titanium back plate 7.8 mm BR (Brown ); BL (Blue)
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
L-T1A
In Commercial Distribution

  • 00862395000214 ()
L-T1A

  • Cornea prosthesis

Boston Keratoprosthesis Click-onType II - 00862395000207

The Boston Keratoprosthesis Click-on Type II Pseudophakia
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
CLF-TIIP
In Commercial Distribution

  • 00862395000207 ()

  • Outer Diameter: 4.5 Millimeter
CLF-TIIP

  • Cornea prosthesis

Boston Keratoprosthesis Click-on Type II - 00862394000291

The Boston Kertoprosthesis Click-on Type II Aphakia
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
CLF-TIIA
In Commercial Distribution

  • 00862394000291 ()

  • Outer Diameter: 4.5 Millimeter
CLF-TIIA

  • Cornea prosthesis
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