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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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Albumin Gen.2 - 07613336120941

No Description
Roche Diagnostics GmbH
08056692190
In Commercial Distribution

  • 07613336120941 ()
08056692190

  • Albumin IVD, kit, spectrophotometry

CryoPRO™-2 - B039SGI00910

CryoPRO™-2 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0091
In Commercial Distribution

  • B039SGI00911 ()
  • B039SGI00910 ()
  • B039SGI00919 ()


  • Blood cell freeze/thaw system

UroLift® 2 - 00814932020032

No Description
NEOTRACT, INC.
UL500-H
In Commercial Distribution

  • 10814932020039 ()
  • 00814932020032 ()
UL500-H

  • Prostatic retraction implant

UroLift® 2 - 00814932020025

No Description
NEOTRACT, INC.
UL500-C
In Commercial Distribution

  • 10814932020022 ()
  • 00814932020025 ()
  • 20814932020029 ()
UL500-C

  • Prostatic retraction implant

UroLift® 2 - 00814932020018

No Description
NEOTRACT, INC.
UL500-H
Not in Commercial Distribution

  • 10814932020015 ()
  • 00814932020018 ()
UL500-H

  • Prostatic retraction implant

Endovapor®2 - 04250337103974

joimax® Endovapor®2 Device Dual High Frequency System
Joimax GmbH
JEVD0202
In Commercial Distribution

  • 04250337103974 ()


  • Electrosurgical system generator

FreeStyle Libre 2 - 00357599805005

FreeStyle Libre 2 Flash Glucose Monitoring System Reader
ABBOTT DIABETES CARE INC
71951
In Commercial Distribution

  • 30357599805006 ()
  • 00357599805005 ()
71951

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

FreeStyle Libre 2 - 00357599804008

FreeStyle Libre 2 Flash Glucose Monitoring System Reader
ABBOTT DIABETES CARE INC
71952
In Commercial Distribution

  • 30357599804009 ()
  • 00357599804008 ()
71952

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

FreeStyle Libre 2 - 00357599803001

FreeStyle Libre 2 Flash Glucose Monitoring System Reader
ABBOTT DIABETES CARE INC
71953
In Commercial Distribution

  • 30357599803002 ()
  • 00357599803001 ()
71953

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

FreeStyle Libre 2 - 00357599800000

FreeStyle Libre 2 Flash Glucose Monitoring System Sensor
ABBOTT DIABETES CARE INC
71992
In Commercial Distribution

  • 30357599800001 ()
  • 00357599800000 ()
71992

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
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