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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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Fifty50 Sport - 00892896000260

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 - 00892896000093

Fifty50 Blood Glucose Test Strip
i-SENS, Inc.
163604
In Commercial Distribution

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


  • Glucose IVD, reagent

Fifty50 - 00892896000086

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 - 00892896000017

Fifty50 Blood Glucose Test Strip
i-SENS, Inc.
163140
In Commercial Distribution

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


  • Glucose IVD, reagent

IPD - 08435566643125

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

IPD - 08435566643101

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

IPD - 08435566643088

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

IPD - 08435566643064

Scanflag - Long Bone Wing
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566643064 ()
ROE/AB-SR-03/FS

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

IPD - 08435566643057

Scanflag - Jut Wing
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566643057 ()
ROE/AB-SR-02/FS

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

IPD - 08435566643040

Scanflag - Wingless Scan body
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566643040 ()
ROE/AB-SR-01/FS

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