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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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Sure-endo - 08809264299425

Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #000, 100 in (254cm)
SURE DENT CORPORATION
SCP-000
In Commercial Distribution

  • 08809264299425 ()


  • Gingival retraction cord, medicated

Sure-endo - 08809264299418

Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #000.0, 100 in (254cm)
SURE DENT CORPORATION
SCP-000.0
In Commercial Distribution

  • 08809264299418 ()


  • Gingival retraction cord, medicated

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

COM.TEC - 04086000860154

The COM.TEC Blood Cell Separator is a blood cell separator which utilizes centrifugal force as the basis for operation. The fields of application are as follows: - Plasma exchange - Plasma treatment
Fresenius Kabi AG
9008031
In Commercial Distribution

  • 04086000860154 ()
9008031

  • Apheresis system

AMICUS Exchange Kit - Therapeutics - 04086000101950

For Therapeutic Plasma Exchange (TPE) Procedure. For Red Blood Cell Exchange (RBCX) Procedures. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
X6R2349
In Commercial Distribution

  • 04086000101950 ()
  • 14086000101957 ()
X6R2349

  • Therapeutic plasma/red blood cell exchange 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

Gel Cord Topical Hemostatic Gel ProPack - 00310866000855

25% aluminum sulfate gel; 25 - 0.75g syringes
PASCAL COMPANY, INC.
15540
In Commercial Distribution

  • 00310866000855 ()
  • 00310866001708 ()

  • Weight: 0.75 Gram
15540

  • Gingival retraction solution

Gel Cord Clear Topical Hemostatic Gel ProPack - 00310866000831

25% aluminum sulfate gel, 12 - 0.75g syringe; no color
PASCAL COMPANY, INC.
15840
In Commercial Distribution

  • 00310866000831 ()
  • 00310866001715 ()

  • Weight: 0.75 Gram
15840

  • Gingival retraction solution

Retrax Solution 15 mL - 00310866000817

Flavored Hemostatic retraction solution for topical dental application with 25% aluminum sulfate, 15 mL
PASCAL COMPANY, INC.
15600
In Commercial Distribution

  • 00310866000817 ()
15600

  • Gingival retraction solution
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