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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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STERIZONE® BI+ Self-contained Biological Indicator - 00690455426021

The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) (Figure 1) is a self-contained stand-alone biological monitor intended to provide users with a means to assess spore kill by the vaporized 125-280 Solution™ (50 wt% hydrogen peroxide) injected in the STERIZONE® VP4 Sterilizer.
TSO3 Inc
42602-1
In Commercial Distribution

  • 00690455426021 ()
  • 00690455750218 ()
42602-1

  • Biological sterilization indicator

SurePass CTR NS Blade - 00860011634836

Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Blade
Dev4
CT-2003NS
In Commercial Distribution

  • 00860011634836 ()
  • 10860011634833 ()


  • Manual scalpel blade, reusable

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 - 08435566630200

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

IPD - 08435566630132

Healing abutment Ø 5.7 H 5.0
IMPLANT PROTESIS DENTAL 2004 SL
TC
In Commercial Distribution

  • 08435566630132 ()
IPD/FA-DW-05

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

IPD - 08435566630125

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

IPD - 08435566630095

Custom Ti Base Non-Engaging Ø 4.5/5.0 GH 2.5
IMPLANT PROTESIS DENTAL 2004 SL
INC3D
In Commercial Distribution

  • 08435566630095 ()
IPD/EA-IW-05/3D

  • Dental implant suprastructure, permanent, preformed
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