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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ONE STEP DETEX ASSOCIATES
DPC-114
In Commercial Distribution

  • 10858917006113 ()
  • 00858917006116 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Endodontic Irrigation Liquid for Removal of Smear Layer of Root Canal
ESSENTIAL DENTAL SYSTEMS, INC.
770-02
In Commercial Distribution

  • 00766054000112 ()

  • Total Volume: 2 Fluid Ounce
  • One - 2 ounce bottle
770-02

  • Root canal cleaning solution
Two-In-One Endodontic Irrigation Liquid for Cleansing a Root Canal
ESSENTIAL DENTAL SYSTEMS, INC.
760-16
In Commercial Distribution

  • 00766054000105 ()

  • One - 16 ounce Bottle
  • Total Volume: 16 Fluid Ounce
760-16

  • Root canal cleaning solution
Endodontic Irrigation and Cleansing Liquid for a Root Canal
ESSENTIAL DENTAL SYSTEMS, INC.
750-16
In Commercial Distribution

  • 00766054000099 ()

  • One - 16 ounce Bottle
  • Total Volume: 16 Fluid Ounce
750-16

  • Root canal cleaning solution
CARE ONE FLTMATE
APOTHECARY PRODUCTS, LLC
F407-006CO1
In Commercial Distribution

  • 20023185000355 ()
  • 00041520875563 ()
  • 10023185000693 ()


  • Earplugs, reusable
CARE ONE KIDS PLUGS
APOTHECARY PRODUCTS, LLC
C265CO1
In Commercial Distribution

  • 20023185000324 ()
  • 00041520875556 ()
  • 10023185000662 ()
  • 40023185002650 ()


  • Earplugs, single-use
CARE ONE COMFORT PLUGS 10PR
APOTHECARY PRODUCTS, LLC
68000CO1
In Commercial Distribution

  • 20023185000348 ()
  • 00041520875549 ()
  • 10023185000686 ()
  • 40023185680001 ()


  • Earplugs, single-use
CARE ONE SILICONE 6 PR 6/144
APOTHECARY PRODUCTS, LLC
F406-906CO1
In Commercial Distribution

  • 20023185000331 ()
  • 00041520875532 ()
  • 10023185000679 ()
  • 40023185069066 ()


  • Earplugs, single-use
LacriCATH kit DCR508-UNIT contains one lacrimal duct catheter 5mm, one AQL 1015 inflation device, and one LIS052 STENTube intubation device.
QUEST MEDICAL INC
DCR508-UNIT
In Commercial Distribution

  • 20634624438518 ()


  • Lacrimal intubation set
LacriCATH DCP315-UNIT contains one lacrimal duct catheter (3mm), and one AQL 1015 Inflation device.
QUEST MEDICAL INC
DCP315-UNIT
In Commercial Distribution

  • 20634624438310 ()


  • Lacrimal intubation set
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