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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Moderate Plus Profile BOOST, For Use With SMPB-185
MENTOR TEXAS L.P.
RSZMPB185S
In Commercial Distribution

  • 00081317027195 ()
RSZ-MPB-185S

  • Invasive breast implant sizer, fixed, reusable
Moderate Plus Profile BOOST, For Use With SMPB-130
MENTOR TEXAS L.P.
RSZMPB130S
In Commercial Distribution

  • 00081317027171 ()
RSZ-MPB-130S

  • Invasive breast implant sizer, fixed, reusable
CORiTEC disc, diameter 98.5 mm, height 20 mm
pro3dure medical GmbH
clear transparent, height 20 mm
In Commercial Distribution

  • 01111111111123 ()
PEMCR00020

  • Custom-made mouthguard
CORiTEC disc, diameter 98.5 mm, height 16 mm
pro3dure medical GmbH
clear transparent, height 16 mm
In Commercial Distribution

  • 01111111111116 ()
PEMCR00016

  • Custom-made mouthguard
ApexPilot , Apex Locator, Rechargeable Battery
Beyes Dental Canada Inc
AL2040
In Commercial Distribution

  • 00990010301351 ()
ApexPilot

  • Endodontic apex locator
Accurator A1
Beyes Dental Canada Inc
AL2010
In Commercial Distribution

  • 00990010301320 ()
Accurator A1

  • Endodontic apex locator
ApexPilot G2,Endo Motor, Connectable to Apex Locator
Beyes Dental Canada Inc
AL2060
In Commercial Distribution

  • 00990010301245 ()
ApexPilot G2

  • Endodontic apex locator
Accurator A2, Apex Locator, compatible with G2 Endo Motor
Beyes Dental Canada Inc
AL2080
In Commercial Distribution

  • 00990010301221 ()
Accurator A2

  • Endodontic apex locator
ApexPilot G1, Endo Motor
Beyes Dental Canada Inc
AL2050
In Commercial Distribution

  • 00990010301252 ()
ApexPilot G1

  • Endodontic apex locator
ApexPilot G3,Endo Motor with Built-in Apex Locator
Beyes Dental Canada Inc
AL2070
In Commercial Distribution

  • 00990010301238 ()
ApexPilot G3

  • Endodontic apex locator
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