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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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AMICUS Exchange Kit - Therapeutics - 04086000101950

For Therapeutic Plasma Exchange (TPE) Procedure. For Red Blood Cell Exchange (RBCX) Procedures. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
X6R2349
In Commercial Distribution

  • 04086000101950 ()
  • 14086000101957 ()
X6R2349

  • Therapeutic plasma/red blood cell exchange tubing set

InQwire® Amplatz - 00884450239476

No Description
Merit Medical Systems, Inc.
00884450239476
In Commercial Distribution

  • 10884450239473 ()
  • 00884450239476 ()
  • 20884450239470 ()

  • Tip Shape-3 mm J-Tip
  • Length-260 cm (102")
  • Configuration-Amplatz Exchange
  • Length-260 cm (102"); Tip Shape-3 mm J-Tip; Length-260 cm (102"); Configuration-Amplatz Exchange
  • Configuration-Amplatz Exchange; Tip Shape-3 mm J-Tip; Length-260 cm (102"); Configuration-Amplatz Exchange
IQA502

  • Cardiac/peripheral vascular guidewire, single-use

BladderScan® - 00879123008015

BladderScan® Prime Plus™ Probe, Probe Exchange
VERATHON INC
Prime Plus™
In Commercial Distribution

  • 10879123008012 ()
  • 00879123008015 ()
E570-0395

  • Bladder ultrasound imaging transducer

Orthopaedic Surgical Instruments - 08059386743072

Fracture alignment guide wire exchange tool, Hudson joint
CITIEFFE SRL
Fracture align. guide wire exchange tool, Hudson
In Commercial Distribution

  • 08059386743072 ()
DT030016

  • Orthopaedic bone-fragment manipulator, reusable

Arndt - 00827002576254

Arndt Airway Exchange Catheter Set with Rapi-Fit Adapters
COOK INCORPORATED
G57625
In Commercial Distribution

  • 00827002576254 ()
C-CAE-14.0-70-LMA-01

  • Endotracheal tube guide, single-use

OTOVIEW - 00821925027411

REPAIR EXCHANGE OTOVIEW SCOPE 2.4 MM 0 DEGREE
Gyrus ACMI, LLC
REX23-5210
In Commercial Distribution

  • 00821925027411 ()


  • Otoscope, endoscopic

OTOVIEW - 00821925027213

REPAIR EXCHANGE OTOVIEW SCOPE 1.7 MM 30 DEGREES
Gyrus ACMI, LLC
REX23-5201
In Commercial Distribution

  • 00821925027213 ()


  • Otoscope, endoscopic

OTOVIEW - 00821925027206

REPAIR EXCHANGE OTOVIEW SCOPE 1.7 MM 0 DEGREES
Gyrus ACMI, LLC
REX23-5200
In Commercial Distribution

  • 00821925027206 ()


  • Otoscope, endoscopic

OTOVIEW - 00821925027190

REPAIR EXCHANGE OTOVIEW SCOPE 2.4 MM 70 DEGREES
Gyrus ACMI, LLC
REX23-5212
In Commercial Distribution

  • 00821925027190 ()


  • Otoscope, endoscopic

OTOVIEW - 00821925027183

REPAIR EXCHANGE OTOVIEW SCOPE 2.4 MM 30 DEGREES
Gyrus ACMI, LLC
REX23-5211
In Commercial Distribution

  • 00821925027183 ()


  • Otoscope, endoscopic
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