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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Leg Compression Sleeves (Small)
VIVE HEALTH LLC
RHB1097S
In Commercial Distribution

  • 10818323028178 ()
  • 00818323028171 ()


  • Portable sequential venous compression system
No Description
MHC MEDICAL PRODUCTS, LLC
810001
In Commercial Distribution

  • MHC18100012 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system
No Description
MHC MEDICAL PRODUCTS, LLC
809050
In Commercial Distribution

  • MHC18090502 ()
  • MHC18090500 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system
No Description
MHC MEDICAL PRODUCTS, LLC
809001
In Commercial Distribution

  • MHC18090012 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system
No Description
MHC MEDICAL PRODUCTS, LLC
807050
In Commercial Distribution

  • MHC18070502 ()
  • MHC8070500 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system
No Description
MHC MEDICAL PRODUCTS, LLC
807001
In Commercial Distribution

  • MHC18070012 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system
Hema-Glu is a dental desensitizing agent to be placed under dental cements or other restorative materials to desensitize and aid bonding primers in penetrating etched dentin.
HEALTHDENT'L, LLC
HG10020
In Commercial Distribution

  • D799HG100200 ()

  • Total Volume: 10 Milliliter
HG10020

  • Dental coating, tooth-desensitizing
Fluoride containing dentin cleaning agent to desensitize and clean a prepared tooth prior to placement of an amalgam restoration or placement of a crown &/or bridge.
HEALTHDENT'L, LLC
HG10010
In Commercial Distribution

  • D799HG100100 ()

  • Total Volume: 10 Milliliter
HG10010

  • Dental coating, tooth-desensitizing
No.
Dreve Otoplastik GmbH
0565
In Commercial Distribution

  • E23905651 ()
0565

  • Moisture/lubrication otic solution
No.
Dreve Otoplastik GmbH
056
In Commercial Distribution

  • E2390561 ()
056

  • Moisture/lubrication otic solution
Fluoride varnish
ICP, INC.
42-2750M
In Commercial Distribution

  • D771422750M1 ()
  • D771422750M0 ()
42-2750M

  • Dental coating, tooth-desensitizing
No Description
ICP, INC.
42-2750BG
In Commercial Distribution

  • D771422750BG1 ()
  • D771422750BG0 ()
42-2750BG

  • Dental coating, tooth-desensitizing
Health-Tec Clear Fluoride Varnish 0.5ml Melon 200 pack
Dental Health Products Inc
950-10081
In Commercial Distribution

  • D773950100813C ()
  • D773950100812 ()
  • D773950100810 ()

  • 0.5ml
950-10081

  • Dental coating, tooth-desensitizing
Health-Tec Clear Fluoride Varnish 0.5ml Mint 200 pack
Dental Health Products Inc
950-10080
In Commercial Distribution

  • D773950100802 ()
  • D773950100800 ()
  • D773950100803 ()

  • 0.5ml
950-10080

  • Dental coating, tooth-desensitizing
Health-Tec Clear Fluoride Varnish 0.5ml Melon 50 pack
Dental Health Products Inc
950-10071
In Commercial Distribution

  • D773950100713B ()
  • D773950100712 ()
  • D773950100710 ()

  • 0.5ml
950-10071

  • Dental coating, tooth-desensitizing
Health-Tec Clear Fluoride Varnish 0.5ml Mint 50 pack
Dental Health Products Inc
950-10070
In Commercial Distribution

  • D773950100702 ()
  • D773950100700 ()
  • D773950100703 ()

  • 0.5ml
950-10070

  • Dental coating, tooth-desensitizing
Health-Tec Desensitizer with Fluoride, 10ml
Dental Health Products Inc
220-10001
In Commercial Distribution

  • D773220100011 ()

  • Total Volume: 10 Milliliter
220-10001

  • Dental coating, tooth-desensitizing
5% Clear Sodium Fluoride Varnish Melon Ind
DARBY DENTAL SUPPLY, LLC
22103
Not in Commercial Distribution

  • 00889813003121 ()
22103

  • Dental coating, tooth-desensitizing
5% Clear Sodium Fluoride Varnish Mint 50ct
DARBY DENTAL SUPPLY, LLC
9510026
Not in Commercial Distribution

  • 00889813003114 ()
  • 00889813003107 ()
  • 10889813003104 ()
9510026

  • Dental coating, tooth-desensitizing
5% Clear Sodium Fluoride Varnish Mint Ind
DARBY DENTAL SUPPLY, LLC
22104
Not in Commercial Distribution

  • 00889813003107 ()
22104

  • Dental coating, tooth-desensitizing
DENTIN DESENSITIZER 10ML
DARBY DENTAL SUPPLY, LLC
G6
In Commercial Distribution

  • 00889813001875 ()
9515140

  • Dental coating, tooth-desensitizing
DENTIN DESENSITIZER G W/GLUT DARBY
DARBY DENTAL SUPPLY, LLC
9515147
In Commercial Distribution

  • 00889813010105 ()
9515147

  • Dental coating, tooth-desensitizing
DENTIN DESENSITIZER B W/FLRDE DARBY
DARBY DENTAL SUPPLY, LLC
9515146
In Commercial Distribution

  • 00889813010099 ()
9515146

  • Dental coating, tooth-desensitizing
Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative detection of antibodies to Helicobacter pylori in whole blood, serum, or plasma.
BTNX Inc
HPY-13C15
In Commercial Distribution

  • 00722066000304 ()
  • 00722066004258 ()
HPY-13C15

  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
FluoriMax 2.5% NaF Varnish Salted CARAMEL Flavor Labeled Bottle
ELEVATE ORAL CARE, LLC
530MT1018
In Commercial Distribution

  • 00858290006215 ()
  • 00858290006253 ()
  • 00858290006246 ()
  • 00858290006260 ()

  • Total Volume: 12 Milliliter
530CM1018

  • Dental coating, tooth-desensitizing
Leg Compression Pump (Premium)
VIVE HEALTH LLC
RHB2025
In Commercial Distribution

  • 10810041983203 ()
  • 00810041983206 ()


  • Portable sequential venous compression system
Leg Compression Sleeve (Medium)
VIVE HEALTH LLC
RHB1097M
In Commercial Distribution

  • 10810041986891 ()
  • 00810041986894 ()


  • Portable sequential venous compression system
5% Sodium Fluoride Natural Varnish (Bubblegum) - 200 Units
NANOVA BIO MATERIALS INC
VAR41P200
In Commercial Distribution

  • 30816537020036 ()
  • 00816537020035 ()
VAR41P200

  • Dental coating, tooth-desensitizing
LIQUID
KURARAY NORITAKE DENTAL INC.
#1217-KA
In Commercial Distribution

  • EKUR001217KA1 ()


  • Dental coating, tooth-desensitizing
POWDER
KURARAY NORITAKE DENTAL INC.
#1216-KA
In Commercial Distribution

  • EKUR001216KA1 ()


  • Dental coating, tooth-desensitizing
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