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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DenSureFit is an over-the-counter soft reline kit. It consists of 2 applicators of vinyl polysiloxane, 1 vial primer, 2 stick applicators and 1 IFU. The kit is intended to reline one denture plate. It is intended to provide temporary relief from ill-fitting dentures until a dentist can be seen.
OTC DENTAL CORPORATION
DSF212.00
In Commercial Distribution

  • 00863995000109 ()


  • Denture reliner, soft, home-use
OTC Remover in 4 Liter Bottle
PARKELL, INC.
S833
In Commercial Distribution

  • 00810000525744 ()
S833

  • Denture reliner, soft, professional
OTC Primer in 4-Litre Bottles
PARKELL, INC.
S827
In Commercial Distribution

  • 00810000525591 ()
S827

  • Denture reliner, soft, professional
SaliPen is an electrostimulating device aimed at treating dry mouth.
SALIWELL LTD
OTC
In Commercial Distribution

  • 07290014891005 ()


  • Dry mouth saliva electrical stimulator
Unifine OTC Pen Needle, 5mm x 31G, 50 ct
OWEN MUMFORD USA INCORPORATED
AN 3651
In Commercial Distribution

  • 00761059651031 ()
  • 00761059651000 ()
  • 00384703550001 ()

  • Needle Gauge: 31 Gauge
  • Length: 5 Millimeter


  • Autoinjector needle
Unifine OTC Pen Needle, 5mm x 31G, 100 ct
OWEN MUMFORD USA INCORPORATED
AN 3650
In Commercial Distribution

  • 00761059650027 ()
  • 00761059650003 ()
  • 00761059650034 ()
  • 00384703550001 ()

  • Needle Gauge: 31 Gauge
  • Length: 5 Millimeter


  • Autoinjector needle
Unifine OTC Pen Needles 4mm x 32G 50 ct
OWEN MUMFORD USA INCORPORATED
AN 3641
In Commercial Distribution

  • 00761059641032 ()
  • 00761059641001 ()
  • 00384703540002 ()

  • Needle Gauge: 32 Gauge
  • Length: 4 Millimeter


  • Autoinjector needle
Unifine OTC Pen Needle 4mm x 32G 100 ct
OWEN MUMFORD USA INCORPORATED
AN 3640
In Commercial Distribution

  • 00761059640028 ()
  • 00761059640004 ()
  • 00761059640035 ()
  • 00384703540002 ()

  • Needle Gauge: 32 Gauge
  • Length: 4 Millimeter


  • Autoinjector needle
The Stork, Merck Femibion
STORK IB2C, INC., THE
1000-033
In Commercial Distribution

  • 00810396020335 ()


  • Conceptive cervical cap, single-use
Stork OTC, Walgreens, S-Box
STORK IB2C, INC., THE
1000-031
In Commercial Distribution

  • 00810396020311 ()


  • Conceptive cervical cap, single-use
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