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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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TPE Plasma Exchange Set - 04086000901543

Therapeutic plasma exchange, disposable variant of 9400401 (Therapeutic plasma exchange, red blood cell exchange).
Fresenius Kabi AG
9400451
In Commercial Distribution

  • 04086000901550 ()
  • 04086000901543 ()
9400451

  • Apheresis system tubing set

Blood Component Filter Set with Vented Spike and Luer Adapter - 04086000100168

For use with the AMICUS separator. Sterile Fluid Path.
Fresenius Kabi AG
X6C2170
In Commercial Distribution

  • 04086000100168 ()
  • 14086000100165 ()
X6C2170

  • Blood transfusion set, non-exchange

AMICUS Exchange Kit - 04086000100151

For Therapeutic Plasma Exchange (TPE) Procedure. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
X6R2339
In Commercial Distribution

  • 04086000100151 ()
  • 14086000100158 ()
X6R2339

  • Therapeutic plasma/red blood cell exchange tubing set

Traxodent - 00348783013283

Traxodent Unit Dose Value Pack
PREMIER DENTAL PRODUCTS COMPANY
9007090
In Commercial Distribution

  • 00348783013283 ()


  • Gingival retraction solution

Knit-Pak - 00348783001921

SAMPLE – Knit-Pak™ Knitted Retraction Size 00 (19.7”)
PREMIER DENTAL PRODUCTS COMPANY
9007559
In Commercial Distribution

  • 00348783001921 ()


  • Gingival retraction cord, non-medicated

Knit-Pak - 00348783001914

Knit-Pak™ Knitted Retraction Size 3
PREMIER DENTAL PRODUCTS COMPANY
9007556
In Commercial Distribution

  • 00348783001914 ()


  • Gingival retraction cord, non-medicated

Knit-Pak - 00348783001907

Knit-Pak™ Knitted Retraction Size 2
PREMIER DENTAL PRODUCTS COMPANY
9007555
In Commercial Distribution

  • 00348783001907 ()


  • Gingival retraction cord, non-medicated

Knit-Pak - 00348783001891

Knit-Pak™ Knitted Retraction Size 1
PREMIER DENTAL PRODUCTS COMPANY
9007554
In Commercial Distribution

  • 00348783001891 ()


  • Gingival retraction cord, non-medicated

Knit-Pak - 00348783001884

Knit-Pak™ Knitted Retraction Size 0
PREMIER DENTAL PRODUCTS COMPANY
9007553
In Commercial Distribution

  • 00348783001884 ()


  • Gingival retraction cord, non-medicated

Knit-Pak - 00348783001877

Knit-Pak™ Knitted Retraction Size 00
PREMIER DENTAL PRODUCTS COMPANY
9007552
In Commercial Distribution

  • 00348783001877 ()


  • Gingival retraction cord, non-medicated
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