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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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Irix-A Lumbar Integrated Fusion System - M697X08038281524TSTR1

IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 24°, 15mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382815-24T-STR
In Commercial Distribution

  • M697X08038281524TSTR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 24°, 15mm height


  • Metallic 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

UROPASS II - 00821925007192

UROPASS II Open Tip Ureteral Stent 6.0 FR X 24 cm
Gyrus ACMI, LLC
5436024
In Commercial Distribution

  • 00821925007192 ()


  • Polymeric ureteral stent

DOUBLE-J - 00821925006553

8.5FR(2.81mm)X 24 cm SURGITEK DOUBLE-J CLOSED TIP URETERAL STENT
Gyrus ACMI, LLC
5209800
In Commercial Distribution

  • 00821925006553 ()


  • Polymeric ureteral stent

DOUBLE-J - 00821925006478

7.0FR(2.3mm) X 24 cm SURGITEK DOUBLE-J CLOSED TIP URETERAL STENT
Gyrus ACMI, LLC
5204800
In Commercial Distribution

  • 00821925006478 ()


  • Polymeric ureteral stent

DOUBLE-J - 00821925006386

6.0FR(2mm) X 24 cm SURGITEK DOUBLE-J CLOSED TIP URETERAL STENT
Gyrus ACMI, LLC
5202800
In Commercial Distribution

  • 00821925006386 ()


  • Polymeric ureteral stent

TriLeap Lower Extremity Anatomic Plating System - 00810112594881

3.5 mm Ti Variable Angle Screw Length 24 mm, Dark Purple
CROSSROADS EXTREMITY SYSTEMS
3.5 mm Ti Variable Angle Screw Length 24 mm, Dark Purple
In Commercial Distribution

  • 00810112594881 ()
04.910.024

  • Orthopaedic bone screw (non-sliding)

TriLeap Lower Extremity Anatomic Plating System - 00810112594362

3.0 mm Ti Variable Angle Screw Length 24 mm, Rose Red
CROSSROADS EXTREMITY SYSTEMS
3.0 mm Ti Variable Angle Screw Length 24 mm, Rose Red
In Commercial Distribution

  • 00810112594362 ()
04.908.024

  • Orthopaedic bone screw (non-sliding)

Avenger - 00810021866369

Avenger Radial Head Stem Implant, Size Ø6.5 x 24 mm, +4mm
IN2BONES USA, LLC
M70 SC365
In Commercial Distribution

  • 00810021866369 ()
M70 SC365

  • Elbow radius prosthesis

Avenger - 00810021866352

Avenger Radial Head Stem Implant, Size Ø5.5 x 24 mm, +4mm
IN2BONES USA, LLC
M70 SC355
In Commercial Distribution

  • 00810021866352 ()
M70 SC355

  • Elbow radius prosthesis
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