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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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Nucleus - 09321502043205

Custom Sound Suite 5.1 CD
COCHLEAR LIMITED
P1257243
In Commercial Distribution

  • 09321502043205 ()
P1257243

  • Audiometric/hearing device software

ResScan - 00619498313327

RESSCAN V 5.9 CD ASSY
RESMED PTY LTD
31332
In Commercial Distribution

  • 00619498313327 ()
31332

  • Ventilator application software

ResScan - 00619498313303

RESSCAN V 5.8 CD ASSY
RESMED PTY LTD
31330
In Commercial Distribution

  • 00619498313303 ()
31330

  • Ventilator application software

ResScan - 00619498313297

RESSCAN V 5.7 CD ASSY
RESMED PTY LTD
31329
In Commercial Distribution

  • 00619498313297 ()
31329

  • Ventilator application software

RESSCAN - 00619498313273

RESSCAN V 5.5 CD ASSY
RESMED PTY LTD
31327
In Commercial Distribution

  • 00619498313273 ()
31327

  • Ventilator application software

EasyCare Tx - 00619498259458

EasyCare Tx V9.0 CD ASSY
RESMED PTY LTD
25945
In Commercial Distribution

  • 00619498259458 ()
25945

  • Ventilator application software

n/a - 04961333231607

CD,5109 REV.A V 3.4.1
PENTAX OF AMERICA, INC.
7194-1000
In Commercial Distribution

  • 04961333231607 ()


  • Electroglottograph

n/a - 04961333231577

CD, GAMES 5167B VERSION 3.3.0
PENTAX OF AMERICA, INC.
7193-2200
In Commercial Distribution

  • 04961333231577 ()


  • Electroglottograph

n/a - 04961333231515

CD, 3506 VERSION 3.3, REV.D
PENTAX OF AMERICA, INC.
7188-0100
In Commercial Distribution

  • 04961333231515 ()


  • Electroglottograph

n/a - 04961333231508

CD, 5104 VERSION 3.2,REV.C
PENTAX OF AMERICA, INC.
7187-9900
In Commercial Distribution

  • 04961333231508 ()


  • Electroglottograph
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