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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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ASTRA-OCT Dia. 4mm CoCr Occipital Rod, 200mm x 60deg (120deg)
SPINECRAFT, LLC
A3OR-40-6020K
Not in Commercial Distribution

  • 00193082082733 ()
  • M824A3OR406020K1 ()
A3OR-40-6020K

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 4mm Ti Occipital Rod, 200mm x 60deg (120deg)
SPINECRAFT, LLC
A3OR-40-6020
Not in Commercial Distribution

  • 00193082082153 ()
  • M824A3OR4060201 ()
A3OR-40-6020

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm CoCr Occipital Rod, 325mm x 90deg (90deg)
SPINECRAFT, LLC
A3OR-35-9032K
Not in Commercial Distribution

  • 00193082082528 ()
  • M824A3OR359032K1 ()
A3OR-35-9032K

  • Bone-screw internal spinal fixation system rod
PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKM1303121S
In Commercial Distribution

  • H965PKM1303121S1 ()
  • H965PKM1303121S0 ()
  • 15051684029865 ()

  • Catheter Gauge: 4 French
  • Length: 55 Centimeter
  • Single


  • Peripherally-inserted central venous catheter
PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKM0104314S
In Commercial Distribution

  • H965PKM0104314S1 ()
  • H965PKM0104314S0 ()
  • 15051684029773 ()

  • Catheter Gauge: 5 French
  • Dual
  • Length: 55 Centimeter


  • Peripherally-inserted central venous catheter
PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKM0104312S
In Commercial Distribution

  • H965PKM0104312S1 ()
  • H965PKM0104312S0 ()
  • 15051684029766 ()

  • Length: 55 Centimeter
  • Catheter Gauge: 4 French
  • Single


  • Peripherally-inserted central venous catheter
BioFlo PICC with ENDEXO Technology (4F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit
NAVILYST MEDICAL, INC.
75-067
In Commercial Distribution

  • H965750670 ()
  • H965750671 ()
  • 15051684026871 ()

  • Catheter Gauge: 4 French
  • Length: 55 Centimeter
  • Needle Gauge: 21 Gauge
  • Outer Diameter: 1.4 Millimeter
  • Pressure: 220 Pound per Square Inch


  • Peripherally-inserted central venous catheter
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology (6F x 55cm, Triple Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit.
NAVILYST MEDICAL, INC.
75-066
In Commercial Distribution

  • H965750660 ()
  • H965750661 ()
  • 15051684026512 ()

  • Outer Diameter: 2.11 Millimeter
  • Needle Gauge: 21 Gauge
  • Pressure: 268 Pound per Square Inch
  • Length: 55 Centimeter
  • Catheter Gauge: 6 French


  • Peripherally-inserted central venous catheter
BioFlo PICC with ENDEXO and PASV Valve Technology (6F x 55cm, Triple Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit.
NAVILYST MEDICAL, INC.
75-065
In Commercial Distribution

  • H965750650 ()
  • H965750651 ()
  • 15051684026505 ()

  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 6 French
  • Pressure: 268 Pound per Square Inch
  • Length: 55 Centimeter
  • Outer Diameter: 2.11 Millimeter


  • Peripherally-inserted central venous catheter
BioFlo PICC with ENDEXO and PASV Valve Technology (6F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit.
NAVILYST MEDICAL, INC.
75-064
In Commercial Distribution

  • H965750640 ()
  • H965750641 ()
  • 15051684026499 ()

  • Outer Diameter: 1.94 Millimeter
  • Length: 55 Centimeter
  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 6 French
  • Pressure: 221 Pound per Square Inch


  • Peripherally-inserted central venous catheter
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