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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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SciPharm NewCore, Core Build-Up Restorative Automix - D801SP57011N1

NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Cartridge. White Opaque. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 57-011 N
In Commercial Distribution

  • D801SP57011N1 ()
57-011 N

  • Dental composite resin

ICU Medical - 00887709098176

Transpac™IT Monitoring Kit, 32", 30ml Flush Device, 10 cc Contamination Syringe and Sampling Port
ICU MEDICAL, INC.
42800-40
In Commercial Distribution

  • 10887709098173 ()
  • 00887709098176 ()
42800-40

  • Invasive blood pressure transducer set

ICU Medical - 00887709067097

Monitoring Kit w/TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve
ICU MEDICAL, INC.
46112-65
In Commercial Distribution

  • 10887709067094 ()
  • 00887709067097 ()
46112-65

  • Invasive blood pressure transducer set

Parky - 00860009869707

Parky App is a symptom tracker mobile app for Parkinson’s Disease patients. It collects motion data through Apple Watch continuously and quantifies tremor and dyskinesia episodes based on clinically validated MM4PD algorithm. Tracked symptoms are reported as daily, weekly and monthly. Each report is shared with the prescribing healthcare professional through email.
H2O BILISIM YAZILIM ELEKTRONIK SAGLIK HIZMETLERI SANAYI VE TICARET LIMITED SIRKETI
V1
In Commercial Distribution

  • 00860009869707 ()


  • Tremor transducer

MASTERGRAFT® STRIP - 00613994407801

STRIP 7800320 MASTERGRAFT STRIP 20CM
MEDTRONIC SOFAMOR DANEK, INC.
7800320
In Commercial Distribution

  • 00613994407801 ()

  • 12 CC each volume
  • Length: 10.0 Centimeter
  • 0.6cm Thickness
  • Width: 2.0 Centimeter


  • Bone matrix implant, animal-derived, bioabsorbable

Combo Kits - 00690103210453

Pressure Monitoring Set
Edwards Lifesciences LLC
PXVPZ30008
In Commercial Distribution

  • 50690103210458 ()
  • 00690103210453 ()

  • Volume 3 cc; Length 84 inches
PXVPZ30008

  • Invasive-pressure external transducer, single-use

TruWave, VAMP Plus - 00690103200409

Pressure Monitoring Set
Edwards Lifesciences LLC
PXVPL0113
In Commercial Distribution

  • 50690103200404 ()
  • 00690103200409 ()

  • Volume 3 cc; Length 84 inches
PXVPL0113

  • Arterial blood sampling kit
  • Invasive-pressure external transducer, single-use

TruWave, VAMP Plus - 00690103200386

Pressure Monitoring Set
Edwards Lifesciences LLC
PXVPL0111
In Commercial Distribution

  • 50690103200381 ()
  • 00690103200386 ()

  • Volume 3 cc; Length 84 inches
PXVPL0111

  • Arterial blood sampling kit
  • Invasive-pressure external transducer, single-use

Combo Kit - 00690103200324

Pressure Monitoring Set
Edwards Lifesciences LLC
PXVMPL260
In Commercial Distribution

  • 50690103200329 ()
  • 00690103200324 ()

  • Length 160 cm Volume 3 cc
PXVMPL260

  • Invasive-pressure external transducer, single-use
  • Arterial blood sampling kit

Combo Kit - 00690103200317

Pressure Monitoring Set
Edwards Lifesciences LLC
PXVMPL172
In Commercial Distribution

  • 50690103200312 ()
  • 00690103200317 ()

  • Length 65 inches, volume 3 cc
PXVMPL172

  • Invasive-pressure external transducer, single-use
  • Arterial blood sampling kit
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