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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Argon Basic EPD Grande Femoral Drape 86" x 135" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396120
Not in Commercial Distribution

  • 20886333212464 ()
  • 00886333212460 ()

  • 86" x 135"
396120

  • Patient surgical drape, single-use
Basic Adult EPD Femoral Angio Drape 75" x 125" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396112
Not in Commercial Distribution

  • 20886333212457 ()
  • 00886333212453 ()

  • 75" x 125"
396112

  • Patient surgical drape, single-use
Basic Adult EPD Femoral Angio Drape 75" x 125" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396111
Not in Commercial Distribution

  • 20886333212440 ()
  • 00886333212446 ()

  • 75" x 125"
396111

  • Patient surgical drape, single-use
Basic Adult EPD Femoral Angio Drape 75" x 125" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396110
In Commercial Distribution

  • 20886333212433 ()
  • 00886333212439 ()

  • 75" x 125"
396110

  • Angiographic drape
No Description
PIVOTAL HEALTH SOLUTIONS, INC.
EPD Package 2
In Commercial Distribution

  • 00850008449550 ()


  • Head/neck procedure positioner
Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001235 ()


  • Electroencephalograph
Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001051 ()


  • Electroencephalograph
Baha 5 Smart App
Cochlear Bone Anchored Solutions AB
P736025
Not in Commercial Distribution

  • 09321502034180 ()
P736025

  • Hearing aid/implant system remote control
Baha 5 Smart App
Cochlear Bone Anchored Solutions AB
95448
Not in Commercial Distribution

  • 09321502034159 ()
95448

  • Hearing aid/implant system remote control
Osia Smart App (Android)
COCHLEAR LIMITED
P1340354
In Commercial Distribution

  • 09321502046145 ()
P1340354

  • Audiometric/hearing device software
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