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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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ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES
Medcad
MC-KTP000-H
In Commercial Distribution

  • 00864582000274 ()
MC-KTP000-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Allereye® is a rapid immunoassay for the detection of total IgE in tears.
BLUEJAY DIAGNOSTICS, INC.
01
In Commercial Distribution

  • 00864525000408 ()
380003G

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
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
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
microTargeting(TM) Drive Mount Adapter for use with NexFrame
FHC, INC.
66-DM-02-00429
In Commercial Distribution

  • 00873263001837 ()
  • 00873263004296 ()
66-DM-02

  • Neurosurgical micro targeting drive
microTargeting(TM) Controller Power Assist System for use with mT Drive or STar Drive M/E
FHC, INC.
66-DS-PA-00427
In Commercial Distribution

  • 00873263004272 ()
66-DS-PA

  • Neurosurgical micro targeting drive
MacroStim Interface
FHC, INC.
66-EL-MI-00422
In Commercial Distribution

  • 00873263004227 ()
66-EL-MI

  • Neurosurgical micro targeting drive
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