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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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Red Blood Cell Exchange Set
TERUMO BCT, INC.
70700
In Commercial Distribution

  • 05020583707009 ()
  • 35020583707000 ()
70700

  • Blood transfer set
Needle Driver and Anchor Exchange
Apollo Endosurgery, Inc.
ESS-ESG-NXT
In Commercial Distribution

  • 00811955020834 ()
ESS-ESG-NXT

  • Suturing unit, single-use
Needle Driver and Anchor Exchange
Apollo Endosurgery, Inc.
ESS-G02-NXT
In Commercial Distribution

  • 00811955020896 ()
  • 10811955020893 ()
ESS-G02-NXT

  • Suturing unit, single-use
No Description
ASAHI KASEI MEDICAL AMERICA INC.
066I
In Commercial Distribution

  • 10868465000112 ()
  • 00868465000115 ()
066I

  • Apheresis system tubing set
No Description
ASAHI KASEI MEDICAL AMERICA INC.
064I
In Commercial Distribution

  • 10868465000105 ()
  • 00868465000108 ()
064I

  • Apheresis system tubing set
For Therapeutic Plasma Exchange (TPE) Procedure. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
X6R2339
In Commercial Distribution

  • 04086000100151 ()
  • 14086000100158 ()
X6R2339

  • Therapeutic plasma/red blood cell exchange tubing set
Lens Exchange System LES G25 three unit package
VISIONCARE OPHTHALMIC TECHNOLOGIES LTD.
G25
In Commercial Distribution

  • M687PR104013 ()
  • M687PR104001 ()
PR00104-01

  • Intraocular lens implantation cord
Lens Exchange System LES G23 three unit package
VISIONCARE OPHTHALMIC TECHNOLOGIES LTD.
G23
In Commercial Distribution

  • M687PR103013 ()
  • M687PR103001 ()
PR00103-01

  • Intraocular lens implantation cord
No Description
SORIN GROUP ITALIA SRL
5100-3118
In Commercial Distribution

  • 08033178019460 ()


  • Mobile extracorporeal gas exchange system catheter kit
No Description
SORIN GROUP ITALIA SRL
5100-2916
In Commercial Distribution

  • 08033178019453 ()


  • Mobile extracorporeal gas exchange system catheter kit
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