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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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Bonita Pit and Fissure Sealant - D820BONNT0

Pit and Fissure Sealant, Dental.
DENALI CORPORATION
1.2 mL Natural Translucent
In Commercial Distribution

  • D820BONNT0 ()
  • D820BONNT1 ()
BONNT

  • Dental pit/fissure sealant

AuraVeneer Cement - D820AVOW

Cement, Dental.
DENALI CORPORATION
Off White
In Commercial Distribution

  • D820AVOW1 ()
  • D820AVOW ()
AVOW

  • Dental composite resin

AuraVeneer Cement - D820AVC0

Cement, Dental.
DENALI CORPORATION
Clear
In Commercial Distribution

  • D820AVC0 ()
  • D820AVC1 ()
AVC

  • Dental composite resin

Aura Protective Sealer - D820APS0

Protective Sealer, Dental.
DENALI CORPORATION
1.2 mL Clear
In Commercial Distribution

  • D820APS0 ()
  • D820APS1 ()
APS

  • Dental pit/fissure sealant

AuraOpaquer - D820AOW0

Opaquer, Dental.
DENALI CORPORATION
1.2 mL White
In Commercial Distribution

  • D820AOW1 ()
  • D820AOW0 ()
AOW

  • Dental composite resin

AuraOpaquer - D820AOP0

Opaquer, Dental.
DENALI CORPORATION
1.2 mL Pink
In Commercial Distribution

  • D820AOP0 ()
  • D820AOP1 ()
AOP

  • Dental composite resin

AuraCore Buildup Material - D820ACOREEOW0

Core Buildup Material, Dental.
DENALI CORPORATION
Single - Opaque White
In Commercial Distribution

  • D820ACOREEOW0 ()
  • D820COREEOW1 ()
COREEOW

  • Dental composite resin

Medegen Medical products - HY3621870

Sharps: 23 Qt. Btl Red
MEDEGEN MEDICAL PRODUCTS, LLC
187
In Commercial Distribution

  • H3621872 ()
  • HY3621870 ()
187

  • Sharps container

NOVA LED Light Source Pencil - HS101125

The NOVA is a Electrosurgical Pencil that has 3 LED battery powered located at the distal end for better visualization of the surgical field. The NOVA can be fitted with a smoke shroud that will remove the smoke plume from the site.The device is designed to work with all standard Electrosurgical Generators.
Pare Surgical, Inc
Hand Switching
In Commercial Distribution

  • HS101125 ()
  • HS112ESUPENCILS ()
900018

  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

BioFlo - H965PKMR61072272S0

PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKMR61072272S
In Commercial Distribution

  • H965PKMR61072272S1 ()
  • H965PKMR61072272S0 ()

  • Length: 55 Centimeter
  • Catheter Gauge: 5 French
  • Dual


  • Peripherally-inserted central venous catheter
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