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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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Dover - 10192253030457

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 12 FR (4.0 MM), 5 CC, 2-WAY
Cardinal Health 200, LLC
20512ICC
Not in Commercial Distribution

  • 20192253030454 ()
  • 10192253030457 ()
  • 50192253030455 ()
20512ICC

  • Indwelling urethral drainage balloon catheter, antimicrobial

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

HEPRO.US Insulin Syringes attached needle 0.3ml/cc 29G x 5/16" - 00850578007457

Case of 20 boxes of Insulin Syringes attached needle 0.3ml/cc 29G x 5/16"
HEPRO.US INC.
CT - 0.3ml/cc 29G x 5/16"
In Commercial Distribution

  • 00850578007457 ()
  • 85057800745702 ()


  • Insulin syringe/needle, basic

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

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

Motiva Implant Matrix - 07445161014580

Intraoperative, Single Use, Sterile Silicone Breast Sizer Motiva Implant Matrix Round Sizer - Demi 360 cc
Establishment Labs S.A.
SZD-360
In Commercial Distribution

  • 07445161014580 ()
SZD-360

  • Invasive breast implant sizer, fixed, single-use

Motiva Implant Matrix - 07445161014573

Intraoperative, Single Use, Sterile Silicone Breast Sizer Motiva Implant Matrix Round Sizer - Demi 320 cc
Establishment Labs S.A.
SZD-320
In Commercial Distribution

  • 07445161014573 ()
SZD-320

  • Invasive breast implant sizer, fixed, single-use
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