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 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.
163140
In Commercial Distribution

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


  • Glucose IVD, reagent
Custom Ti Base Non-Engaging GM H 4.0
IMPLANT PROTESIS DENTAL 2004 SL
INC3D
In Commercial Distribution

  • 08435566630200 ()
IPD/RB-IR-07/3D

  • Dental implant suprastructure, permanent, preformed
Custom Ti Base Engaging GM H 4.0
IMPLANT PROTESIS DENTAL 2004 SL
INC3D
In Commercial Distribution

  • 08435566630194 ()
IPD/RB-IR-06/3D

  • Dental implant suprastructure, permanent, preformed
Healing abutment Ø 5.7 H 3.0
IMPLANT PROTESIS DENTAL 2004 SL
TC
In Commercial Distribution

  • 08435566630125 ()
IPD/FA-DW-03

  • Dental implant suprastructure, temporary, preformed, single-use
Temporary abutment Non-Engaging Ø 3,0
IMPLANT PROTESIS DENTAL 2004 SL
PP
In Commercial Distribution

  • 08435566630026 ()
IPD/AD-PT-07

  • Dental implant suprastructure, temporary, preformed, single-use
Ti Screw TiN Ø 3.5 GM Micro
IMPLANT PROTESIS DENTAL 2004 SL
TTN
In Commercial Distribution

  • 08435566628597 ()
IPD/RD-TN-00/TIN

  • Dental prosthesis/implant abutment screw
Ti Screw Ø 3.3 GM Micro
IMPLANT PROTESIS DENTAL 2004 SL
TT
In Commercial Distribution

  • 08435566628573 ()
IPD/RD-TN-00

  • Dental prosthesis/implant abutment screw
TPA Screw Standard
IMPLANT PROTESIS DENTAL 2004 SL
TPA
In Commercial Distribution

  • 08435566623868 ()
IPD/TB-TR-50

  • Dental prosthesis/implant abutment screw
Temporary abutment Engaging Standard
IMPLANT PROTESIS DENTAL 2004 SL
PP
In Commercial Distribution

  • 08435566623783 ()
IPD/TB-PR-06

  • Dental implant suprastructure, temporary, preformed, single-use
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