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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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12mm Rasp
Pioneer Surgical Technology, Inc.
83-RASP-12
Not in Commercial Distribution

  • 00846468047856 ()
83-RASP-12

  • Bone file/rasp, manual, reusable
8mm Dilator
Pioneer Surgical Technology, Inc.
83-DILATOR-08
Not in Commercial Distribution

  • 00846468047795 ()
83-DILATOR-08

  • Nerve/vessel retractor
5mm Dilator
Pioneer Surgical Technology, Inc.
83-DILATOR-05
Not in Commercial Distribution

  • 00846468047788 ()
83-DILATOR-05

  • Nerve/vessel retractor
Barrel Plate Inserter
Pioneer Surgical Technology, Inc.
83-B-INSERTER
Not in Commercial Distribution

  • 00846468047757 ()
83-B-INSERTER

  • General internal orthopaedic fixation system implantation kit
No Description
SPECTRUM MEDICAL SRL
VT75-C2U
In Commercial Distribution

  • 18051160301857 ()


  • Extracorporeal membrane oxygenator
No Description
SPECTRUM MEDICAL SRL
CGSP8-B1
In Commercial Distribution

  • 18051160303097 ()


  • Cardioplegia solution administration kit
No Description
SPECTRUM MEDICAL SRL
CGSP8-B0
In Commercial Distribution

  • 18051160302809 ()


  • Cardioplegia solution administration kit
No Description
Starkey Laboratories, Inc.
EVOLV AI IIC NW
In Commercial Distribution

  • 00842318189837 ()


  • Air-conduction hearing aid, canal
  • Tinnitus masking application software
No Description
Starkey Laboratories, Inc.
EVOLV AI HS R
In Commercial Distribution

  • 00842318189721 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, canal
No Description
Starkey Laboratories, Inc.
EVOLV AI ITE R
In Commercial Distribution

  • 00842318189714 ()


  • Air-conduction hearing aid, in-the-ear
  • Tinnitus masking application software
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