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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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AzaDrox™ Rx Wound Gel is a wound dressing hydrogel that helps maintain a moist wound environment that is conducive to healing by either absorbing or donating moisture and wound exudates.
ALVIX LABORATORIES, LLC
FP1020-1
In Commercial Distribution

  • 00315455957039 ()


  • Wound hydrogel dressing, non-sterile
BoneMedik-DM is a coralline hydroxyapatite and a more active tricalcium phosphate bone grafting material for dental and craniofacial usage. It is comprised of 60% silicon substituted hydroxyapatite and 40% [3-tricalcium phosphate.
Meta Biomed Co., Ltd.
9718
In Commercial Distribution

  • 08806387897187 ()


  • Tungsten-weighted oesophageal dilator
StimQ Freedom-8A Receiver Kit Channel A US w/ Receiver StimQ Peripheral Nerve Stimulator System
STIMWAVE TECHNOLOGIES INCORPORATED
FR8A-RCV-A0
In Commercial Distribution

  • 00818225020815 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter


  • Analgesic implantable peripheral nerve electrical stimulation system
StimQ Peripheral Nerve Stimulator System StimQ Freedom-8A Trial Kit Channel A US w/ Receiver
STIMWAVE TECHNOLOGIES INCORPORATED
FR8A-TRL-A0
In Commercial Distribution

  • 00818225020792 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter


  • Analgesic implantable peripheral nerve electrical stimulation system
StimQ Peripheral Nerve Stimulator System StimQ Freedom-8A Spare Kit Channel A US w/ Receiver
STIMWAVE TECHNOLOGIES INCORPORATED
FR8A-SPR-A0
In Commercial Distribution

  • 00818225020778 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter


  • Analgesic implantable peripheral nerve electrical stimulation system
StimQ Peripheral Nerve Stimulator System StimQ Freedom-4A Spare Kit Channel A US w/ Receiver
STIMWAVE TECHNOLOGIES INCORPORATED
FR4A-SPR-A0
In Commercial Distribution

  • 00818225020754 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter


  • Analgesic implantable peripheral nerve electrical stimulation system
StimQ Peripheral Nerve Stimulator System StimQ Freedom-4A Receiver Kit Channel A US w/ Receiver
STIMWAVE TECHNOLOGIES INCORPORATED
FR4A-RCV-A0
In Commercial Distribution

  • 00818225020730 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter


  • Analgesic implantable peripheral nerve electrical stimulation system
StimQ Peripheral Nerve Stimulator System StimQ Freedom-4A Trial Kit Channel A US w/ Receiver
STIMWAVE TECHNOLOGIES INCORPORATED
FR4A-TRL-A0
In Commercial Distribution

  • 00818225020716 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter


  • Analgesic implantable peripheral nerve electrical stimulation system
StimQ Peripheral Nerve Stimulator System StimQ Receiver Stimulator Kit Channel A US w/Receiver
STIMWAVE TECHNOLOGIES INCORPORATED
STQ4-RCV-A0
In Commercial Distribution

  • 00818225020464 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter


  • Analgesic implantable peripheral nerve electrical stimulation system
Phasor Drill 6.35-mm diameter, ~70-mm length with drill stop extension (untapered) + Kit (version A)
PHASOR HEALTH LLC
PH-635-70-D + PH-K-A
In Commercial Distribution

  • B775PH63570DPHKA0 ()
PH-635-70-D + PH-K-A

  • Craniotomy power tool system, battery-powered, single-use
  • Neurosurgical procedure kit, medicated
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