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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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Lateral flow immunoassay for the detection of Phencyclidine (PCP) in urine.
GERMAINE LABORATORIES, INC
49125
In Commercial Distribution

  • 00695684491253 ()
  • 00695684491251 ()


  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
Pulmonary Valve SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human tissue.
Artivion, Inc.
SGPV10
In Commercial Distribution

  • 00877234000454 ()

  • Internal Diameter: Ranges from 6mm to 32mm (allograft specific)
SGPV10

  • Cadaveric heart valve prosthesis, decellularized, non-sterile
Pulmonary Valve and Conduit SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human tissue.
Artivion, Inc.
SGPV00
In Commercial Distribution

  • 00877234000447 ()

  • Internal Diameter: Ranges from 6mm to 32mm (allograft specific)
SGPV00

  • Cadaveric heart valve prosthesis, decellularized, non-sterile
Facet Lag Screw, 4.5mm x 54mm
Seaspine Orthopedics Corporation
58-1454
In Commercial Distribution

  • 10889981143183 ()

  • 4.5mm x 54mm
58-1454

  • Trans-facet-screw internal spinal fixation system, sterile
SleepRight ProRx Custom-Fit Dental Guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Splintek Inc.
ProRx
In Commercial Distribution

  • 00692121035216 ()


  • Custom-made mouthguard
No Description
Sonoma Pharmaceuticals, Inc.
85024
In Commercial Distribution

  • 20868489000287 ()
  • 00868489000283 ()

  • Total Volume: 80 Milliliter
85024

  • Eyelid solution
No Description
Sonoma Pharmaceuticals, Inc.
85023
In Commercial Distribution

  • 20868489000270 ()
  • 00868489000276 ()

  • Total Volume: 40 Milliliter
85023

  • Eyelid solution
Facet Lag Screw 4.5MM x 55MM
Seaspine Orthopedics Corporation
58-1455
In Commercial Distribution

  • 10889981077037 ()

  • 4.5MM x 55MM
58-1455

  • Trans-facet-screw internal spinal fixation system, sterile
Facet Lag Screw 4.5MM x 46MM
Seaspine Orthopedics Corporation
58-1446
In Commercial Distribution

  • 10889981077006 ()

  • 4.5MM x 46MM
58-1446

  • Trans-facet-screw internal spinal fixation system, sterile
Facet Lag Screw 4.5MM x 42MM
Seaspine Orthopedics Corporation
58-1442
In Commercial Distribution

  • 10889981076979 ()

  • 4.5MM x 42MM
58-1442

  • Trans-facet-screw internal spinal fixation system, sterile
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