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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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Absorb GT1 Bioresorbable Vascular Scaffold System 2.50 mm x 12 mm / Rapid-Exchange
ABBOTT VASCULAR INC.
1235250-12
Not in Commercial Distribution

  • 08717648212949 ()
1235250-12

  • Drug-eluting coronary artery stent, fully-bioabsorbable
Absorb GT1 Bioresorbable Vascular Scaffold System 2.50 mm x 8 mm / Rapid-Exchange
ABBOTT VASCULAR INC.
1235250-08
Not in Commercial Distribution

  • 08717648212932 ()
1235250-08

  • Drug-eluting coronary artery stent, fully-bioabsorbable
3000 Series High Temperature Drape for use with CODMAN O.R. Heater AP-09100
Cerenovus, Inc.
AP-09150
Not in Commercial Distribution

  • 20886704043826 ()
  • 10886704043829 ()
AP09150

  • Implantable intrathecal infusion pump, nonprogrammable
Personal Programmer Model 8001
Envoy Medical Corporation
8001
In Commercial Distribution

  • 00812282020078 ()
908001-101

  • Fully-implantable middle ear implant system
SEDASYS DISPLAY MONITOR
ETHICON ENDO-SURGERY, INC.
SED15LCD
Not in Commercial Distribution

  • 20705036010224 ()
SED15LCD

  • Intraprocedural physiologic-monitoring sedation system
SEDASYS AUTOMATED RESPONSIVENESS MONITOR
ETHICON ENDO-SURGERY, INC.
SEDARM01
Not in Commercial Distribution

  • 30705036003568 ()
  • 20705036003561 ()
SEDARM01

  • Intraprocedural physiologic-monitoring sedation system
Silicone Gel Sizer, Smooth Shaped, Oval Base, Moderate Projection, 475 cc
Sientra, Inc.
GSOBASE-475MP
In Commercial Distribution

  • 00819409025220 ()

  • Volume: 475 cc
GSOBASE-475MP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Sizer, Smooth Shaped, Oval Base, Moderate Projection, 450 cc
Sientra, Inc.
GSOBASE-450MP
In Commercial Distribution

  • 00819409025213 ()

  • Volume: 450 cc
GSOBASE-450MP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Sizer, Smooth Shaped, Oval Base, Moderate Projection, 425 cc
Sientra, Inc.
GSOBASE-425MP
In Commercial Distribution

  • 00819409025206 ()

  • Volume: 425 cc
GSOBASE-425MP

  • Silicone gel-filled breast implant, textured-surface
Silicone Gel Sizer, Smooth Shaped, Oval Base, Moderate Projection, 400 cc
Sientra, Inc.
GSOBASE-400MP
In Commercial Distribution

  • 00819409025190 ()

  • Volume: 400 cc
GSOBASE-400MP

  • Silicone gel-filled breast implant, textured-surface
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