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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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PET UNIT DOSE - 00718175001752

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

Ionto Plus Large Electrode - 00092237901779

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

AoN Implants - 00840192704535

Contra Angle Prosthetic Fixing Key D.1.20 mm. Short L.9 mm. - CC- IH - EH
FAICO MEDICAL LLC
AST12SHOPRCAI
Not in Commercial Distribution

  • 00840192704535 ()


  • Dental implant system

AoN Implants - 00840192704528

Contra Angle Prosthetic Fixing Key D.1.20 mm. Long L.14 mm. - CC- IH - EH
FAICO MEDICAL LLC
AST12000PRCAI
Not in Commercial Distribution

  • 00840192704528 ()


  • Dental implant system

USA Elite - 00821925003309

USA Elite System Cystourethroscope Cawood Deflecting Bridge, Double-Horn 23-25 Fr, (7.7-8.3 mm) CC Yellow/Green
Gyrus ACMI, LLC
E158
In Commercial Distribution

  • 00821925003309 ()


  • Rigid optical cystourethroscope

USA Elite - 00821925003255

USA Elite System Cystourethroscope Albarran Deflecting Bridge, Double-Horn 23-25 Fr, (7.7-8.3 mm) CC Yellow/Green
Gyrus ACMI, LLC
E152
In Commercial Distribution

  • 00821925003255 ()


  • Rigid optical cystourethroscope

SciPharm NewCore, Core Build-Up Restorative Automix - D801SP57031

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

SciPharm NewCore, Core Build-Up Restorative Automix - D801SP57011

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

Dentorium - 05056079040985

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

  • 05056079040985 ()
AC2S05102

  • Denture base resin kit

Dentorium - 05056079040978

Cold Cure Denture Base Powder
WRIGHT HEALTH GROUP LIMITED
Convertible CC 5kg Dark Vnd
In Commercial Distribution

  • 05056079040978 ()
AC2S05104

  • Denture base resin kit
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