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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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Ultraxx Nephrostomy Balloon Clear Amplatz Sheath with Radiopaque Stripe
COOK INCORPORATED
G57620
In Commercial Distribution

  • 00827002576209 ()
UNB-10-15-CS-01

  • Nephrostomy catheter
Ultraxx Nephrostomy Balloon Clear Amplatz Sheath with Radiopaque Stripe
COOK INCORPORATED
G57618
In Commercial Distribution

  • 00827002576186 ()
UNB-6-15-CS-01

  • Nephrostomy catheter
Ultraxx Nephrostomy Balloon with TFE Sheath
COOK INCORPORATED
G57616
In Commercial Distribution

  • 00827002576162 ()
UNB-8-15-01

  • Nephrostomy catheter
Universa Malecot Drainage Catheter Suprapubic Set
COOK INCORPORATED
G56335
In Commercial Distribution

  • 00827002563353 ()
UMCP-10-15

  • Nephrostomy catheter
Universa Malecot Drainage Catheter Suprapubic Set
COOK INCORPORATED
G56334
In Commercial Distribution

  • 00827002563346 ()
UMCP-8-15

  • Nephrostomy catheter
Skater™ Nephrostomy Catheter Locking Pigtail 14Fr x 25cm
ARGON MEDICAL DEVICES, INC.
755614025E
In Commercial Distribution

  • 20886333001242 ()
  • 00886333001248 ()

  • 14Fr x 25cm
755614025

  • Nephrostomy catheter
Skater™ Nephrostomy Catheter Non-Locking 14F x 35cm
ARGON MEDICAL DEVICES, INC.
755514035E
In Commercial Distribution

  • 20886333001235 ()
  • 00886333001231 ()

  • 14F x 35cm
755514035

  • Nephrostomy catheter
Skater™ Nephrostomy Catheter Non-Locking 14F x 25cm
ARGON MEDICAL DEVICES, INC.
755514025E
In Commercial Distribution

  • 20886333001228 ()
  • 00886333001224 ()

  • 14F x 25cm
755514025

  • Nephrostomy catheter
Skater™ Nephrostomy Catheter Locking Pigtail 12Fr x 25cm
ARGON MEDICAL DEVICES, INC.
755612025E
In Commercial Distribution

  • 20886333001143 ()
  • 00886333001149 ()

  • 12Fr x 25cm
755612025

  • Nephrostomy catheter
Skater™ Nephrostomy Catheter Locking Pigtail 10Fr x 25cm
ARGON MEDICAL DEVICES, INC.
755610025E
In Commercial Distribution

  • 20886333001129 ()
  • 00886333001125 ()

  • 10Fr x 25cm
755610025

  • Nephrostomy catheter
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