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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 - 00847817006791

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

  • 00847817006791 ()
2500014

  • Inherited haemoglobinopathy IVD, reagent

Exchange Select Early Result Pregnancy Test - 00614299402676

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

CrossFAST™ Integrated Microcatheter Advanced Delivery System - 00860007727917

5.5, Catheter with Rapid Exchange Length
Vantis Vascular, Inc.
CFM55
In Commercial Distribution

  • 00860007727917 ()
  • 20860007727911 ()


  • Vascular guide-catheter, single-use

TranS1 - 00815361020297

AxiaLIF Plus Exchange System Fixation Wire
QUANDARY MEDICAL LLC
TR1-2212
In Commercial Distribution

  • 00815361020297 ()


  • Orthopaedic bone wire

WA Holter System - 90815187020290

HR300 Mini Holter Recorder Repair Exchange
GLOBAL INSTRUMENTATION, LLC
HR300
In Commercial Distribution

  • 90815187020290 ()
404955

  • Electrocardiographic ambulatory recorder

Universa - 00827002558342

Universa Malecot Drainage Catheter Exchange Set
COOK INCORPORATED
G55834
In Commercial Distribution

  • 00827002558342 ()
UMC-24-30

  • Nephrostomy catheter

Universa - 00827002558335

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

  • 00827002558335 ()
UMC-22-30

  • Nephrostomy catheter

Universa - 00827002558328

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

  • 00827002558328 ()
UMC-20-30

  • Nephrostomy catheter

Universa - 00827002558311

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

  • 00827002558311 ()
UMC-18-30

  • Nephrostomy catheter

Universa - 00827002558304

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

  • 00827002558304 ()
UMC-16-30

  • Nephrostomy catheter
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