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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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Hemoglobin Variants System Cation Exchange Mini-Columns
BIO-RAD LABORATORIES, INC.
250-0014
In Commercial Distribution

  • 00847817006791 ()
2500014

  • Inherited haemoglobinopathy IVD, reagent
PLPL Exchange Select DPS Early Result
SPD SWISS PRECISION DIAGNOSTICS GMBH
PLPL
In Commercial Distribution

  • 00614299402676 ()
  • 10614299402673 ()
  • 00633472000126 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
5.5, Catheter with Rapid Exchange Length
Vantis Vascular, Inc.
CFM55
In Commercial Distribution

  • 00860007727917 ()
  • 20860007727911 ()


  • Vascular guide-catheter, single-use
AxiaLIF Plus Exchange System Fixation Wire
QUANDARY MEDICAL LLC
TR1-2212
In Commercial Distribution

  • 00815361020297 ()


  • Orthopaedic bone wire
HR300 Mini Holter Recorder Repair Exchange
GLOBAL INSTRUMENTATION, LLC
HR300
In Commercial Distribution

  • 90815187020290 ()
404955

  • Electrocardiographic ambulatory recorder
Universa Malecot Drainage Catheter Exchange Set
COOK INCORPORATED
G55834
In Commercial Distribution

  • 00827002558342 ()
UMC-24-30

  • Nephrostomy catheter
Universa Malecot Drainage Catheter Exchange Set
COOK INCORPORATED
G55833
In Commercial Distribution

  • 00827002558335 ()
UMC-22-30

  • Nephrostomy catheter
Universa Malecot Drainage Catheter Exchange Set
COOK INCORPORATED
G55832
In Commercial Distribution

  • 00827002558328 ()
UMC-20-30

  • Nephrostomy catheter
Universa Malecot Drainage Catheter Exchange Set
COOK INCORPORATED
G55831
In Commercial Distribution

  • 00827002558311 ()
UMC-18-30

  • Nephrostomy catheter
Universa Malecot Drainage Catheter Exchange Set
COOK INCORPORATED
G55830
In Commercial Distribution

  • 00827002558304 ()
UMC-16-30

  • Nephrostomy catheter
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