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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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No Description
OCEANIC MEDICAL PRODUCTS, INC.
1
Not in Commercial Distribution

  • 00864604000336 ()


  • Anaesthesia unit, mobile
No Description
OCEANIC MEDICAL PRODUCTS, INC.
1
Not in Commercial Distribution

  • 00864604000329 ()


  • Anaesthesia unit, mobile
Individually packaged DeScribe PFD Patch (each)
On Light Sciences, Inc.
PFD-462
In Commercial Distribution

  • 00864525000200 ()
  • 10864525000207 ()


  • Synthetic polymer semi-permeable film dressing, adhesive, non-sterile
No Description
Alcon Laboratories, Inc.
2020-D
In Commercial Distribution

  • 00864461000418 ()
  • 10864461000415 ()
2020-D

  • Eyelid thermal pulsation system applicator, single-use
No Description
N. M. BEALE COMPANY, INC.
USB-OR
Not in Commercial Distribution

  • 00864390000350 ()
USB-OR

  • Ultrasound endoscope balloon, synthetic polymer
No Description
N. M. BEALE COMPANY, INC.
USB-PL
Not in Commercial Distribution

  • 00864390000343 ()
USB-PL

  • Ultrasound endoscope balloon, synthetic polymer
No Description
N. M. BEALE COMPANY, INC.
USB-OL
Not in Commercial Distribution

  • 00864390000336 ()
USB-OL

  • Ultrasound endoscope balloon, synthetic polymer
No Description
N. M. BEALE COMPANY, INC.
NBPT520
Not in Commercial Distribution

  • 00864390000305 ()
NBPT520

  • General specimen container IVD, no additive/medium
3CPM Company Electrogastrogram Research/Waterload platform Unit. Device uses ECG-like technology to capture the electrical waves of the stomach and intestines.
3CPM CO., INC.
2.09e
In Commercial Distribution

  • 00864359000223 ()


  • Myoelectric gastrointestinal motility analysis system
  • Electrocardiograph, professional, single-channel
ZR5, KIT 312 2.4G NFM 85 PB R BE ZERENA 5
Bernafon AG
186060
In Commercial Distribution

  • 05711584084465 ()


  • Air-conduction hearing aid, in-the-ear
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