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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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100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 12 FR (4.0 MM), 5 CC, 2-WAY
Cardinal Health 200, LLC
20512ICC
In Commercial Distribution

  • 20192253066200 ()
  • 10192253066203 ()
  • 50192253066201 ()
20512ICC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
Pig, Unit Dose, PET, 3/5 cc, .5" lead accommodates syringes with or without needle
BIODEX MEDICAL SYSTEMS, INC.
001-785
In Commercial Distribution

  • 00718175001752 ()
001-785

  • Radiation shielding container, transport/transfer
NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Cartridge. White Opaque.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 57-01
In Commercial Distribution

  • D801SP57011 ()
57-01

  • Dental composite resin
NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Cartridge. Blue Shade.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 57-03
In Commercial Distribution

  • D801SP57031 ()
57-03

  • Dental composite resin
Iontophoresis Drug Delivery Large Kit Electrodes - 4.0 cc, 4mA-min incl. buffered return 3.5" x 3.5"
COMPASS HEALTH BRANDS CORP.
201-453
In Commercial Distribution

  • 80092237901775 ()
  • 30092237901770 ()
  • 00092237901779 ()
  • 01092237901778 ()


  • Drug-delivery iontophoresis patch
Irrigation Tray with Bulb Syringe; 1000mL Bulb Irrigation Peel Lid Tray with 60 cc Syringe
Cardinal Health 200, LLC
BIT
In Commercial Distribution

  • 50885380095762 ()
  • 00885380095767 ()
BIT

  • General surgical procedure kit, non-medicated, single-use
Cold Cure Denture Base Powder
WRIGHT HEALTH GROUP LIMITED
Convertible CC 1kg Dark Vnd
In Commercial Distribution

  • 05056079041487 ()
2S05004

  • Denture base resin kit
Cold Cure Denture Base Powder
WRIGHT HEALTH GROUP LIMITED
Convertible CC 5kg Red Vnd
In Commercial Distribution

  • 05056079041449 ()
2S05102

  • Denture base resin kit
Cold Cure Denture Base Powder
WRIGHT HEALTH GROUP LIMITED
Convertible CC 3kg Red Vnd
In Commercial Distribution

  • 05056079041432 ()
2S05302

  • Denture base resin kit
Cold Cure Denture Base Powder
WRIGHT HEALTH GROUP LIMITED
Convertible CC 5kg Red Vnd
In Commercial Distribution

  • 05056079040985 ()
AC2S05102

  • Denture base resin kit
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