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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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R E-MAXTM Vitamin E Ultracongruent Tibial Insert Sz B 12mm
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 200
In Commercial Distribution

  • 00841523101573 ()
1201-232-312

  • Cruciate-retaining total knee prosthesis
R E-MAXTM Vitamin E Ultracongruent Tibial Insert Sz B 10mm
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 200
In Commercial Distribution

  • 00841523101566 ()
1201-232-310

  • Cruciate-retaining total knee prosthesis
R E-MAXTM Vitamin E Ultracongruent Tibial Insert Sz A 20mm
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 200
In Commercial Distribution

  • 00841523101559 ()
1201-232-120

  • Cruciate-retaining total knee prosthesis
R E-MAXTM Vitamin E Ultracongruent Tibial Insert Sz A 17mm
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 200
In Commercial Distribution

  • 00841523101542 ()
1201-232-117

  • Cruciate-retaining total knee prosthesis
R E-MAXTM Vitamin E Ultracongruent Tibial Insert Sz A 14mm
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 200
In Commercial Distribution

  • 00841523101535 ()
1201-232-114

  • Cruciate-retaining total knee prosthesis
R E-MAXTM Vitamin E Ultracongruent Tibial Insert Sz A 12mm
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 200
In Commercial Distribution

  • 00841523101528 ()
1201-232-112

  • Cruciate-retaining total knee prosthesis
R E-MAXTM Vitamin E Ultracongruent Tibial Insert Sz A 10mm
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 200
In Commercial Distribution

  • 00841523101511 ()
1201-232-110

  • Cruciate-retaining total knee prosthesis
For use with Mindray ELC13-4U/E/s EX3™ Stepper
CIVCO MEDICAL INSTRUMENTS CO., INC.
658-006
In Commercial Distribution

  • 00841436121545 ()
658-006

  • Prostate brachytherapy system applicator, manual
E-CIMA Vitamin E Domed Patella Sz 5 42mm 10.0mm Thick
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 200
In Commercial Distribution

  • 00841523143658 ()
1201-344-542

  • Posterior-stabilized total knee prosthesis
E-CIMA Vitamin E Domed Patella Sz 4 38mm 9.5mm Thick
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 200
In Commercial Distribution

  • 00841523143641 ()
1201-344-438

  • Posterior-stabilized total knee prosthesis
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