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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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ThunderBolt EIA (CLIA) - B35000300CLR0

ThunderBolt EIA-CLIA (refurbished)
Gold Standard Diagnostics Corporation
00300-CLR
In Commercial Distribution

  • B35000300CLR0 ()
00300-CLR

  • Enzyme immunoassay (EIA) analyser IVD
  • Chemiluminescent immunoassay analyser IVD

ThunderBolt EIA (CLIA) - B35000300CL0

ThunderBolt EIA-CLIA
Gold Standard Diagnostics Corporation
00300-CL
In Commercial Distribution

  • B35000300CL0 ()
00300CL

  • Enzyme immunoassay (EIA) analyser IVD
  • Chemiluminescent immunoassay analyser IVD

SafeID - 05056190500801

SafeID 2.3
VISION RT LIMITED
SafeID 2.3
In Commercial Distribution

  • 05056190500801 ()


  • Patient-administration information system application software

SafeID - 05056190500467

No Description
VISION RT LIMITED
Pole
Not in Commercial Distribution

  • 05056190500467 ()


  • Patient-administration information system application software

SafeID - 05056190500450

No Description
VISION RT LIMITED
SafeID Kiosk Box
Not in Commercial Distribution

  • 05056190500450 ()


  • Patient-administration information system application software

SafeID - 05056190500429

No Description
VISION RT LIMITED
SafeID Kiosk
In Commercial Distribution

  • 05056190500429 ()


  • Patient-administration information system application software

SafeID - 05056190500405

No Description
VISION RT LIMITED
SafeID 2.1
In Commercial Distribution

  • 05056190500405 ()


  • Patient-administration information system application software

SafeRT-ID - 05056190500375

No Description
VISION RT LIMITED
SafeRT-ID (no interlock)
Not in Commercial Distribution

  • 05056190500375 ()


  • Patient-administration information system application software

SafeID - 05056190500412

No Description
VISION RT LIMITED
SafeID Server WebAPI
In Commercial Distribution

  • 05056190500412 ()


  • Patient-administration information system application software

SafeRT-ID - 05056190500382

No Description
VISION RT LIMITED
SafeRT-ID (with interlock)
Not in Commercial Distribution

  • 05056190500382 ()


  • Patient-administration information system application software
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