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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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TruCath - 00850045818845

TruCath® 100% Silicone Foley Catheter, 24 Fr 30 ml, 2-Way
HR PHARMACEUTICALS INC.
SS2430
In Commercial Distribution

  • 10850045818842 ()
  • 00850045818845 ()
  • 50850045818840 ()


  • Indwelling urethral drainage balloon catheter, non-antimicrobial

TruCath - 00850045818838

TruCath® 100% Silicone Foley Catheter, 24 Fr 10 ml, 2-Way
HR PHARMACEUTICALS INC.
SS2410
In Commercial Distribution

  • 10850045818835 ()
  • 00850045818838 ()
  • 50850045818833 ()


  • Indwelling urethral drainage balloon catheter, non-antimicrobial

TruCath - 00850045818890

TruCath® 100% Silicone Foley Catheter, 24 Fr 30 ml, 3-Way
HR PHARMACEUTICALS INC.
SS24303W
In Commercial Distribution

  • 10850045818897 ()
  • 00850045818890 ()
  • 50850045818895 ()


  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Irix-A Lumbar Integrated Fusion System - M697X08042301924STR1

IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 24°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423019-24-STR
In Commercial Distribution

  • M697X08042301924STR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 24°, 19mm height


  • Metal-polymer composite spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08038281724STR1

IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 24°, 17mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382817-24-STR
In Commercial Distribution

  • M697X08038281724STR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 24°, 17mm height


  • Metal-polymer composite spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08033261724STR1

IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 24°, 17mm (STERILE)
Xtant Medical Holdings, Inc.
X080-332617-24-STR
In Commercial Distribution

  • M697X08033261724STR1 ()

  • Width: 33 Millimeter
  • 26mm depth X 24°, 17mm height


  • Metal-polymer composite spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08038281924STR1

IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 24°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382819-24-STR
In Commercial Distribution

  • M697X08038281924STR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 24°, 19mm height


  • Metal-polymer composite spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697X08033261924STR1

IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 24°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-332619-24-STR
In Commercial Distribution

  • M697X08033261924STR1 ()

  • 26mm depth X 24°, 19mm height
  • Width: 33 Millimeter


  • Metal-polymer composite spinal interbody fusion cage

TruSignal SpO2 - 00840682147293

Replacement Foam Wrap Medium for TruSignal Sensitive Skin sensor, 24 pcs
GE Healthcare Finland Oy
TS-RWM-24
In Commercial Distribution

  • 00840682147293 ()
TS-RWM-24

  • Electrode/transducer strap, reusable

TruSignal SpO2 - 00840682147279

Replacement Foam Wrap Small for TruSignal Sensitive Skin sensor, 24 pcs
GE Healthcare Finland Oy
TS-RWS-24
In Commercial Distribution

  • 00840682147279 ()
TS-RWS-24

  • Electrode/transducer strap, reusable
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