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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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Phasor Drill 5.30-mm diameter, ~70-mm length with drill stop extension (untapered) + Kit (version A)
PHASOR HEALTH LLC
PH-530-70-D + PH-K-A
In Commercial Distribution

  • B775PH53070DPHKA0 ()
PH-530-70-D + PH-K-A

  • Craniotomy power tool system, battery-powered, single-use
  • Neurosurgical procedure kit, medicated
Phasor Drill 4.50-mm diameter, ~70-mm length with drill stop extension (untapered) + Kit (version A)
PHASOR HEALTH LLC
PH-450-70-D + PH-K-A
In Commercial Distribution

  • B775PH45070DPHKA0 ()
PH-450-70-D + PH-K-A

  • Craniotomy power tool system, battery-powered, single-use
  • Neurosurgical procedure kit, medicated
Phasor Drill 2.70-mm diameter, ~70-mm length with Optional Secondary Drill Stop + Kit (Version A)
PHASOR HEALTH LLC
PH-270-70-S + PH-K-A
In Commercial Distribution

  • B775PH27070SPHKA0 ()
PH-270-70-S + PH-K-A

  • Craniotomy power tool system, battery-powered, single-use
  • Neurosurgical procedure kit, medicated
Lyphochek Allergen sIgE Control Panel A MiniPak (An assayed human serum allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000144
In Commercial Distribution

  • 00847661005759 ()
12000144

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control
Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
LIFE SENSING INSTRUMENTS, INC.
TrensCenter 5.400
In Commercial Distribution

  • 00864037000392 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
LIFE SENSING INSTRUMENTS, INC.
TrensCenter VSP 1.000
In Commercial Distribution

  • 00864037000385 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
LIFE SENSING INSTRUMENTS, INC.
TrensCenter 5.300
In Commercial Distribution

  • 00864037000354 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
LIFE SENSING INSTRUMENTS, INC.
TrensCenter VSP 1.100
In Commercial Distribution

  • 00857769008033 ()


  • Electrocardiography telemetric monitoring system
Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
LIFE SENSING INSTRUMENTS, INC.
TrensCenter 6.000
In Commercial Distribution

  • 00857769008019 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
EASY BONE COLLECTOR 6MM LONG MAXIMUM AUTOGENOUS BONE 1 CC WITH A FEW SECONDS
Power Dental U.S.A. Inc.
1982-6
In Commercial Distribution

  • D94319826 ()
1982-6

  • Dressing/utility forceps, scissors-like, reusable
  • Intraoperative orthopaedic bone pin/screw, single-use
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