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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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Shape-HF system
Shape Medical Systems, Inc.
0008-9001
In Commercial Distribution

  • B20089001 ()


  • Pulmonary function analysis system, adult
Shape-HF analyzer
Shape Medical Systems, Inc.
HF001
In Commercial Distribution

  • B200HF001 ()


  • Pulmonary function analysis system, adult
Full Shape II system with paramagnetic analyzer
Shape Medical Systems, Inc.
0008-3012
In Commercial Distribution

  • B20083012 ()


  • Pulmonary function analysis system, adult
Disposable patient interface with filter 0004-4012
Shape Medical Systems, Inc.
0004-4012
In Commercial Distribution

  • B20044012 ()


  • Pulmonary function testing kit
Disposable Patient Interface is part of the Shape-HF testing system
Shape Medical Systems, Inc.
Disposable Patient Interface
In Commercial Distribution

  • B20044001 ()


  • Pulmonary function testing kit
IMPEDE-FX Embolization Plug, 12mm
SHAPE MEMORY MEDICAL INC
IMP-FX-12
In Commercial Distribution

  • 10810041650051 ()
  • 00810041650054 ()
  • B054IMPFX121 ()
IMP-FX-12

  • Extraluminal vascular occluder, single-use
IMPEDE-FX Embolization Plug, 8mm
SHAPE MEMORY MEDICAL INC
IMP-FX-08
In Commercial Distribution

  • 10810041650044 ()
  • 00810041650047 ()
  • B054IMPFX081 ()
IMP-FX-08

  • Extraluminal vascular occluder, single-use
IMPEDE-FX Embolization Plug, 6mm
SHAPE MEMORY MEDICAL INC
IMP-FX-06
In Commercial Distribution

  • 10810041650037 ()
  • 00810041650030 ()
  • B054IMPFX061 ()
IMP-FX-06

  • Extraluminal vascular occluder, single-use
IMPEDE Embolization Plug, 10mm
SHAPE MEMORY MEDICAL INC
IMP-10
In Commercial Distribution

  • 10810041650020 ()
  • 00810041650023 ()
  • B054IMP101 ()
IMP-10

  • Extraluminal vascular occluder, single-use
IMPEDE Embolization Plug, 7mm
SHAPE MEMORY MEDICAL INC
IMP-07
In Commercial Distribution

  • 10810041650013 ()
  • 00810041650016 ()
  • B054IMP071 ()
IMP-07

  • Extraluminal vascular occluder, single-use
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