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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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Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZPN-BS-46E
In Commercial Distribution

  • 00816734022405 ()
  • B019ZPNBS46E0 ()

  • Catheter Gauge: 6.4 French
ZPN-BS-46E

  • Manometric gastrointestinal motility analysis system
LimiTorr™ Volume Limiting External CSF Drainage and Monitoring System
Integra Lifesciences Corporation
INS9030SP1
In Commercial Distribution

  • 10381780071136 ()
  • M269INS9030SP11 ()
INS9030SP1

  • Ventricular cerebrospinal fluid drainage catheterization kit
  • Lumbar cerebrospinal fluid drainage catheterization kit
LimiTorr™ Volume Limiting External CSF Drainage and Monitoring System
Integra Lifesciences Corporation
INS9030
In Commercial Distribution

  • 10381780071129 ()
  • M269INS90301 ()

  • 30ml
INS9030

  • Ventricular cerebrospinal fluid drainage catheterization kit
  • Lumbar cerebrospinal fluid drainage catheterization kit
LimiTorr™ Volume Limiting External CSF Drainage and Monitoring System
Integra Lifesciences Corporation
INS9020SP1
In Commercial Distribution

  • 10381780071112 ()
  • M269INS9020SP11 ()

  • 20ml
INS9020SP1

  • Ventricular cerebrospinal fluid drainage catheterization kit
  • Lumbar cerebrospinal fluid drainage catheterization kit
LimiTorr™ Volume Limiting External CSF Drainage and Monitoring System
Integra Lifesciences Corporation
INS9020
In Commercial Distribution

  • 10381780071105 ()
  • M269INS90201 ()

  • 20ml
INS9020

  • Lumbar cerebrospinal fluid drainage catheterization kit
  • Ventricular cerebrospinal fluid drainage catheterization kit
Hermetic™ II External CSF Drainage Management Replacement Collection Bag
Integra Lifesciences Corporation
NL8508305N
In Commercial Distribution

  • 30381780071659 ()
  • 10381780071655 ()
  • M269NL8508305N1 ()

  • 700 ml
NL8508305N

  • Lumbar cerebrospinal fluid drainage catheterization kit
  • Ventricular cerebrospinal fluid drainage catheterization kit
Male External Catheter, X-Large 41mm, Non Latex w/Skin wipe
The Lighthouse For The Blind
Ultra Flex XL w/wipe
In Commercial Distribution

  • 00009235421871 ()
2204045

  • Urinary incontinence penis sheath/port, single-use
Male External Catheter, Small 25 mm, Non-Latex w/Skin Wipe
The Lighthouse For The Blind
UltraFlex Small w/ wipe
In Commercial Distribution

  • 00009235421796 ()
2204037

  • Urinary incontinence penis sheath/port, single-use
JET-X LARGE - UNILATERAL EXTERNAL FIXATOR SYSTEM OUTER TRAY - SHORT TRAY
Smith & Nephew, Inc.
71067358
In Commercial Distribution

  • 03596010612120 ()
71067358

  • Instrument tray, reusable
JET-X LARGE - UNILATERAL EXTERNAL FIXATOR SYSTEM OUTER TRAY - TALL TRAY
Smith & Nephew, Inc.
71067359
In Commercial Distribution

  • 03596010608109 ()
71067359

  • Instrument tray, reusable
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