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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-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-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
Hemoban® Gel Infusor Tip Refill
DENTSPLY INTERNATIONAL INC.
675120
In Commercial Distribution

  • D0026751200 ()
  • D0026751201 ()

  • 100 Infusor Tips
675120

  • Dental material injection cannula, single-use
Hemoban® Gel Complete Package
DENTSPLY INTERNATIONAL INC.
675130
In Commercial Distribution

  • D0026751101 ()
675110

  • Gingival retraction solution
Whip Mix VeriSplint™ OS is a light-cured resin and sold as Rx only. It is a base polymer used to create removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.
WHIP-MIX CORPORATION
71174
In Commercial Distribution

  • D040711740 ()


  • Dental appliance fabrication material, resin
Whip Mix VeriSplint™ OS is a light-cured resin and sold as Rx only. It is a base polymer used to create removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.
WHIP-MIX CORPORATION
71147
Not in Commercial Distribution

  • D040711471 ()


  • Dental appliance fabrication material, resin
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
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
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
For use with the AMICUS separator. Sterile Fluid Path.
Fresenius Kabi AG
X6C2170
In Commercial Distribution

  • 04086000100168 ()
  • 14086000100165 ()
X6C2170

  • Blood transfusion set, non-exchange
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