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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single use silicon cups to protect head membrane from tearing by stereotactic frame sharp screws during FUS neuro clinical treatment
INSIGHTEC LTD
Neuro Protective Frame Pin Cup
In Commercial Distribution

  • 07290015461306 ()
MPR001164

  • Therapeutic oncological/gynaecological ultrasound system
a multi use ASM001399 for fixing the skull position during neuro FUS clinical treatment
INSIGHTEC LTD
Neuro Stereotactic Frame
In Commercial Distribution

  • 07290015461290 ()
ASM001399

  • Therapeutic oncological/gynaecological ultrasound system
multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment
INSIGHTEC LTD
Neuro Stereotactic Frame Set
In Commercial Distribution

  • 07290015461283 ()
SET400168

  • Therapeutic oncological/gynaecological ultrasound system
Beta Bendini Instrument Base Tray
Nuvasive, Inc.
1592760
In Commercial Distribution

  • 00887517246820 ()


  • Spinal rod bending system
Bendini Rod Bender, Spinal
Nuvasive, Inc.
1592700
In Commercial Distribution

  • 00887517246332 ()


  • Spinal rod bending system
No Description
Biomet Orthopedics, LLC
906064
In Commercial Distribution

  • 00880304454538 ()
906064

  • Arthroscopic shaver system, electrically-powered
Shaver System
STRYKER CORPORATION
SS-100
In Commercial Distribution

  • 00857326005635 ()


  • ENT shaver system
No Description
BEAUTEX LLC
ICB-MM
In Commercial Distribution

  • 00860010319017 ()


  • Dermatological diode laser system
No Description
BEAUTEX LLC
ICB-EM
In Commercial Distribution

  • 00860010319000 ()


  • Dermatological diode laser system
FMS Tornado Shaver Handpiece 8000 RPM
DEPUY MITEK, LLC
288022
In Commercial Distribution

  • 10886705018345 ()
288022

  • Arthroscopic shaver system, electrically-powered
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