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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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ApexPilot - 00990010301252

ApexPilot G1, Endo Motor
Beyes Dental Canada Inc
AL2050
In Commercial Distribution

  • 00990010301252 ()
ApexPilot G1

  • Endodontic apex locator

ApexPilot - 00990010301245

ApexPilot G2,Endo Motor, Connectable to Apex Locator
Beyes Dental Canada Inc
AL2060
In Commercial Distribution

  • 00990010301245 ()
ApexPilot G2

  • Endodontic apex locator

ApexPilot - 00990010301238

ApexPilot G3,Endo Motor with Built-in Apex Locator
Beyes Dental Canada Inc
AL2070
In Commercial Distribution

  • 00990010301238 ()
ApexPilot G3

  • Endodontic apex locator

Accurator - 00990010301221

Accurator A2, Apex Locator, compatible with G2 Endo Motor
Beyes Dental Canada Inc
AL2080
In Commercial Distribution

  • 00990010301221 ()
Accurator A2

  • Endodontic apex locator

Salivea - 00899655002275

Salivea Hydrating Mouth Spray - 1.5 oz bottle in unit carton
LACLEDE, INC.
Dry Mouth MouthSpray
In Commercial Distribution

  • 00899655002275 ()


  • Artificial saliva

Salivea - 00899655002251

Salivea Dry Mouth Mouthwash - 16 oz bottle
LACLEDE, INC.
Dry Mouth Mouthwash
In Commercial Distribution

  • 00899655002251 ()


  • Artificial saliva

Salivea - 00899655002220

Salivea Dry Mouth Moisturizing Gel - 1.0 oz tube in unit carton
LACLEDE, INC.
Dry Mouth Moisturizing Gel
In Commercial Distribution

  • 00899655002220 ()


  • Artificial saliva

Salivea - 00899655002213

Salivea Dry Mouth Mouthwash sample - 2oz
LACLEDE, INC.
Dry Mouth Mouthwash sample
In Commercial Distribution

  • 00899655002213 ()


  • Artificial saliva

Responder® Polysaccharide Hemostat - 00899010002889

RESPONDER® Polysaccharide Hemostat is intended to be used to achieve hemostasis in emergency situations forthe temporary control of severe topical bleeding.
Starch Medical Inc.
RP0025
In Commercial Distribution

  • 10899010002886 ()
  • 00899010002889 ()


  • Plant polysaccharide haemostatic agent, bioabsorbable

Responder® Polysaccharide Hemostat - 00899010002865

RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as minor lacerations, minor cuts and minor abrasions.
Starch Medical Inc.
RP0003
In Commercial Distribution

  • 00899010002698 ()
  • 00899010002865 ()


  • Plant polysaccharide haemostatic agent, bioabsorbable
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