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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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Amplatz - 00827002574649

Amplatz Renal Introducer
COOK INCORPORATED
G57464
In Commercial Distribution

  • 00827002574649 ()
ARI-240016-01

  • Endoscopic-access dilator, single-use

Amplatz - 00827002574632

Amplatz Renal Introducer
COOK INCORPORATED
G57463
In Commercial Distribution

  • 00827002574632 ()
ARI-180016-01

  • Endoscopic-access dilator, single-use

Cook - 00827002574625

Catheter for use with Amplatz Renal Dilator Set
COOK INCORPORATED
G57462
In Commercial Distribution

  • 00827002574625 ()
075001-01

  • Endoscopic-access dilator, single-use

Amplatz - 00827002574618

Amplatz Renal Dilator Set
COOK INCORPORATED
G57461
In Commercial Distribution

  • 00827002574618 ()
AQ-075000-01

  • Fascial tissue dilator, single-use

Amplatz - 00827002574601

Amplatz Renal Dilator Set
COOK INCORPORATED
G57460
In Commercial Distribution

  • 00827002574601 ()
075000-S1-01

  • Fascial tissue dilator, single-use

Amplatz - 00827002574595

Amplatz Renal Dilator Set
COOK INCORPORATED
G57459
In Commercial Distribution

  • 00827002574595 ()
075000-01

  • Fascial tissue dilator, single-use

Ultraxx - 00827002476585

Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe
COOK INCORPORATED
G47658
In Commercial Distribution

  • 00827002476585 ()
UNBS-10-15-CS-01

  • Nephrostomy catheter

Ultraxx - 00827002476493

Ultraxx Nephrostomy Balloon Set
COOK INCORPORATED
G47649
In Commercial Distribution

  • 00827002476493 ()
UNBS-10-15-01

  • Nephrostomy catheter

Ultraxx - 00827002476486

Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe
COOK INCORPORATED
G47648
In Commercial Distribution

  • 00827002476486 ()
UNBS-8-15-CS-01

  • Nephrostomy catheter

Ultraxx - 00827002476479

Ultraxx Nephrostomy Balloon Set
COOK INCORPORATED
G47647
In Commercial Distribution

  • 00827002476479 ()
UNBS-8-15-01

  • Nephrostomy catheter
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