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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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Endovenous Radiofrequency Ablation (RFA) Catheter 7-60
Vein360 LLC
VEN-7-60
Not in Commercial Distribution

  • 08600360005107 ()
VEN-7-60

  • Radio-frequency ablation system
Endovenous Radiofrequency Ablation (RFA) Catheter 3-60
Vein360 LLC
VEN-3-60
Not in Commercial Distribution

  • 08600360005022 ()
VEN-3-60

  • Radio-frequency ablation system
Endovenous Radiofrequency Ablation (RFA) Catheter 7-100
Vein360 LLC
VEN-7-100
Not in Commercial Distribution

  • 08600360005008 ()
VEN-7-100

  • Radio-frequency ablation system
Fifty50 Sport Blood Glucose Monitoring System 2.0
i-SENS, Inc.
163424-201
In Commercial Distribution

  • 00892896000260 ()
  • 10892896000267 ()


  • Home-use/point-of-care blood glucose monitoring system IVD
Fifty50 Blood Glucose Test Strip
i-SENS, Inc.
163604
In Commercial Distribution

  • 20892896000097 ()
  • 10892896000090 ()
  • 00892896000093 ()
  • 50892896000098 ()


  • Glucose IVD, reagent
Fifty50 Blood Glucose Monitoring System 2.0
i-SENS, Inc.
163308-302
In Commercial Distribution

  • 10892896000083 ()
  • 00892896000086 ()


  • Home-use/point-of-care blood glucose monitoring system IVD
Fifty50 Blood Glucose Test Strip
i-SENS, Inc.
163140
In Commercial Distribution

  • 20892896000011 ()
  • 10892896000014 ()
  • 00892896000017 ()
  • 50892896000012 ()


  • Glucose IVD, reagent
Scanflag - Tapered Wing
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566643125 ()
ROE/AB-SR-09/FS

  • Dental implant abutment analog, intraoral-scanning, single-use
Scanflag - Triple Divot Wing
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566643101 ()
ROE/AB-SR-07/FS

  • Dental implant abutment analog, intraoral-scanning, single-use
Scanflag - Long Wavy Wing
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566643088 ()
ROE/AB-SR-05/FS

  • Dental implant abutment analog, intraoral-scanning, single-use
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