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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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Tissue Embedding Center, Cold Module, 230V
RUSHABH INSTRUMENTS, LLC
150CS, 230V
In Commercial Distribution

  • B921119661 ()
119661

  • Tissue embedding unit IVD
Tissue Embedding Center, Cold Module, 115V
RUSHABH INSTRUMENTS, LLC
150CS, 115V
In Commercial Distribution

  • B921119660 ()
119660

  • Tissue embedding unit IVD
Cryo Module (Requires connnection to product code 5108 for operation)
SAKURA FINETEK U.S.A., INC.
5109
In Commercial Distribution

  • 04946433600515 ()
5109

  • Tissue embedding unit IVD
Embedding Module
SAKURA FINETEK U.S.A., INC.
5108
In Commercial Distribution

  • 04946433600508 ()
5108

  • Tissue embedding unit IVD
Plus Cryo Console
SAKURA FINETEK U.S.A., INC.
5250
In Commercial Distribution

  • 04946433600492 ()
5250

  • Tissue embedding unit IVD
Automated Embedder
SAKURA FINETEK U.S.A., INC.
7090
In Commercial Distribution

  • 04946433600362 ()
7090

  • Tissue embedding unit IVD
HistoStar Tissue Embedding System - Accessory
SHANDON DIAGNOSTICS LIMITED
Switch
In Commercial Distribution

  • 05051663518314 ()
AP16629

  • Tissue embedding unit IVD
HistoStar Tissue Embedding System - Accessory
SHANDON DIAGNOSTICS LIMITED
Cable
In Commercial Distribution

  • 05051663518307 ()
AP16125

  • Tissue embedding unit IVD
HistoStar Tissue Embedding System - Accessory
SHANDON DIAGNOSTICS LIMITED
Waste Area Cover
In Commercial Distribution

  • 05051663518246 ()
A81030307

  • Tissue embedding unit IVD
HistoStar Tissue Embedding System - Accessory
SHANDON DIAGNOSTICS LIMITED
Dispense Nozzle Short
In Commercial Distribution

  • 05051663518239 ()
A81030197

  • Tissue embedding unit IVD
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