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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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Blood Component Filter Set with Vented Spike and Luer Adapter - 04086000100168

For use with the AMICUS separator. Sterile Fluid Path.
Fresenius Kabi AG
X6C2170
In Commercial Distribution

  • 04086000100168 ()
  • 14086000100165 ()
X6C2170

  • Blood transfusion set, non-exchange

SOFT PLUG® Silicone Punctum Plug - 00845819006436

SOFT PLUG® Pen Inserter for Silicone Punctum Plug
OASIS MEDICAL, INC.
7700
In Commercial Distribution

  • 00845819006436 ()


  • Lacrimal punctum plug

Lucid Audio - 00846430005990

ER20XS-SMF-C 4 pack of ER20XS for PriceSmart Part# 20196
ETYMOTIC RESEARCH, INC.
ER20XS-SMF-C
In Commercial Distribution

  • 00846430005990 ()


  • Earplugs, reusable

Lucid Audio - 00846430005983

Hearful Pillow Pouch LG ER20XS for Saudi Arabia #20192
ETYMOTIC RESEARCH, INC.
ER20XS LG
In Commercial Distribution

  • 00846430005983 ()


  • Earplugs, reusable

SmartGuard - 00866330000208

Dental mouth guard for clenching and grinding teeth (bruxism)
Smartguard Rx, Inc.
SGDG6
In Commercial Distribution

  • 10866330000205 ()
  • 00866330000208 ()
  • 30866330000209 ()
  • 20866330000202 ()


  • Mouthguard, reusable

PMMA - 00858174006003

PMMA (polymethyl methacrylate) hard contact lens for daily wear
LAGADO CORPORATION, THE
003
In Commercial Distribution

  • 00858174006003 ()


  • Hard corrective contact lens

QuickProfile™ PCP Test Card - M90107RD70220

Immunoassay for the detection of PCP in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7022
In Commercial Distribution

  • M90107RD70221 ()
  • M90107RD70220 ()

  • Length: 75 Millimeter
07RD7022

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

QuickProfile™ PCP Test Strip - M90107RD70210

Immunoassay for the detection of PCP in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7021
In Commercial Distribution

  • M90107RD70211 ()
  • M90107RD70210 ()

  • Length: 75 Millimeter
07RD7021

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Irritrol - 00766054000105

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

Endo-CHX - 00766054000099

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
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