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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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ASURAGEN, INC.
84001
In Commercial Distribution

  • 00863840000285 ()
84001

  • General specimen container IVD, additive/medium
ZR9, KIT 312 NFM 85 PB T L BE ZERENA 9
Bernafon AG
185924
In Commercial Distribution

  • 05711584083956 ()


  • Air-conduction hearing aid, in-the-ear
ZR9, KIT 312 NFM 85 PB L BE ZERENA 9
Bernafon AG
185922
In Commercial Distribution

  • 05711584083932 ()


  • Air-conduction hearing aid, in-the-ear
NovoGro Putty is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
OSTEONOVUS, INC.
NGC10X
In Commercial Distribution

  • 00863787000478 ()

  • 10 cc


  • Bone matrix implant, synthetic, non-antimicrobial
ZR9, KIT 312 NFM 85 L BE ZERENA 9
Bernafon AG
185920
In Commercial Distribution

  • 05711584083918 ()


  • Air-conduction hearing aid, in-the-ear
NovoGro Putty is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
OSTEONOVUS, INC.
NGC025X
In Commercial Distribution

  • 00863787000454 ()

  • 2.5 cc


  • Bone matrix implant, synthetic, non-antimicrobial
ZR9, KIT 312 NFM 75 L BE ZERENA 9
Bernafon AG
185918
In Commercial Distribution

  • 05711584083895 ()


  • Air-conduction hearing aid, in-the-ear
ZR9, KIT 312 NFM 75 R BE ZERENA 9
Bernafon AG
185917
In Commercial Distribution

  • 05711584083888 ()


  • Air-conduction hearing aid, in-the-ear
ZR9, KIT 312 2.4G NFM PB L BE ZERENA 9
Bernafon AG
185914
In Commercial Distribution

  • 05711584083857 ()


  • Air-conduction hearing aid, in-the-ear
Arm blood pressure monitor
1BYONEPRODUCTS INC.
TMB-1585
In Commercial Distribution

  • 00863696000309 ()
  • 00863696000316 ()
  • 10863696000306 ()


  • Telemetric sphygmomanometer
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