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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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Dentorium - 05056079040206

Heat Cure Denture Base Powder
WRIGHT HEALTH GROUP LIMITED
Convertible Acrylic Powder CC Veined 1lb
In Commercial Distribution

  • 05056079040206 ()
AC531

  • Denture base resin kit

GN Otometrics A/S - 05713315000164

No Description
Natus Medical Denmark ApS
2 cc coupler and adapter kit
Not in Commercial Distribution

  • 05713315000164 ()


  • Hearing aid tester, electrical

KyphoFlex™ - 00884450845325

No Description
Merit Medical Systems, Inc.
Initial Release
In Commercial Distribution

  • 10884450845322 ()
  • 00884450845325 ()

  • Max Pressure (psi)-700 psi
  • Balloon Length (mm)-25 mm
  • Max Volume (cc)-7 cc
  • Gauge Size-10G
KPA25A

  • Inflatable bone tamp

KyphoFlex™ - 00884450845318

No Description
Merit Medical Systems, Inc.
Initial Release
In Commercial Distribution

  • 10884450845315 ()
  • 00884450845318 ()

  • Gauge Size-10G
  • Max Volume (cc)-5 cc
  • Max Pressure (psi)-700 psi
  • Balloon Length (mm)-20 mm
KPA20A

  • Inflatable bone tamp

KyphoFlex™ - 00884450845301

No Description
Merit Medical Systems, Inc.
Initial Release
In Commercial Distribution

  • 10884450845308 ()
  • 00884450845301 ()

  • Max Pressure (psi)-700 psi
  • Max Volume (cc)-4 cc
  • Balloon Length (mm)-15 mm
  • Gauge Size-10G
KPA15A

  • Inflatable bone tamp

Arcadia™ - 00884450815786

No Description
Merit Medical Systems, Inc.
G
In Commercial Distribution

  • 00884450815786 ()

  • Max Pressure (psi)-700 psi
  • Max Volume (cc)-8 cc
  • Balloon Length (mm)-30 mm
  • Gauge Size-10G
ARC30SB

  • Inflatable bone tamp

Arcadia™ - 00884450815748

No Description
Merit Medical Systems, Inc.
G
In Commercial Distribution

  • 00884450815748 ()

  • Max Pressure (psi)-700 psi
  • Balloon Length (mm)-25 mm
  • Gauge Size-10G
  • Max Volume (cc)-7 cc
ARC25SB

  • Inflatable bone tamp

Arcadia™ - 00884450815717

No Description
Merit Medical Systems, Inc.
G
In Commercial Distribution

  • 00884450815717 ()

  • Max Volume (cc)-5 cc
  • Balloon Length (mm)-20 mm
  • Max Pressure (psi)-700 psi
  • Gauge Size-10G
ARC20ST

  • Inflatable bone tamp

Arcadia™ - 00884450815540

No Description
Merit Medical Systems, Inc.
G
In Commercial Distribution

  • 00884450815540 ()

  • Balloon Length (mm)-20 mm
  • Gauge Size-10G
  • Max Volume (cc)-5 cc
  • Max Pressure (psi)-700 psi
ARC20SB

  • Inflatable bone tamp

Arcadia™ - 00884450815519

No Description
Merit Medical Systems, Inc.
G
In Commercial Distribution

  • 00884450815519 ()

  • Balloon Length (mm)-15 mm
  • Max Volume (cc)-4 cc
  • Gauge Size-10G
  • Max Pressure (psi)-700 psi
ARC15ST

  • Inflatable bone tamp
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