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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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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

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

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

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 - 07445161014566

Intraoperative, Single Use, Sterile Silicone Breast Sizer Motiva Implant Matrix Round Sizer - Demi 285 cc
Establishment Labs S.A.
SZD-285
In Commercial Distribution

  • 07445161014566 ()
SZD-285

  • Invasive breast implant sizer, fixed, single-use

Motiva Implant Matrix - 07445161014450

Intraoperative, Single Use, Sterile Silicone Breast Sizer Motiva Implant Matrix Round Sizer - Mini 150 cc
Establishment Labs S.A.
SZM-150
In Commercial Distribution

  • 07445161014450 ()
SZM-150

  • Invasive breast implant sizer, fixed, single-use

Motiva Implant Matrix - 07445161009869

Intraoperative, Single Use, Sterile Silicone Breast Sizer Motiva Implant Matrix Round Sizer - Full 145 cc
Establishment Labs S.A.
SZF-145
In Commercial Distribution

  • 07445161009869 ()
SZF-145

  • Invasive breast implant sizer, fixed, single-use

Motiva Implant Matrix - 07445161009845

Intraoperative, Single Use, Sterile Silicone Breast Sizer Motiva Implant Matrix Round Sizer - Demi 575 cc
Establishment Labs S.A.
SZD-575
In Commercial Distribution

  • 07445161009845 ()
SZD-575

  • Invasive breast implant sizer, fixed, single-use

Motiva Implant Matrix - 07445161009821

Intraoperative, Single Use, Sterile Silicone Breast Sizer Motiva Implant Matrix Round Sizer - Demi 475 cc
Establishment Labs S.A.
SZD-475
In Commercial Distribution

  • 07445161009821 ()
SZD-475

  • Invasive breast implant sizer, fixed, single-use
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