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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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DCTAPER - D690213122

DCTAPER ROTARY FILE 30/V06 L25 - 6 PACK
Ss White Burs, Inc.
U21312
In Commercial Distribution

  • D690213120 ()
  • D690213122 ()
21312

  • Rotary/reciprocating endodontic file/rasp, single-use

DCTAPER - D690213042

DCTAPER ROTARY FILE 30/V06 L21 - 6 PACK
Ss White Burs, Inc.
U21304
In Commercial Distribution

  • D690213040 ()
  • D690213042 ()
21304

  • Rotary/reciprocating endodontic file/rasp, single-use

Irix-A Lumbar Integrated Fusion System - M697T08042301924TR1

42 X 30 X 19mm, 24 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423019-24TR
In Commercial Distribution

  • M697T08042301924TR0 ()
  • M697T08042301924TR1 ()

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


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301920TR1

42 X 30 X 19mm, 20 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423019-20TR
In Commercial Distribution

  • M697T08042301920TR0 ()
  • M697T08042301920TR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 19mm height, 20 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301724TR1

42 X 30 X 17mm, 24 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423017-24TR
In Commercial Distribution

  • M697T08042301724TR0 ()
  • M697T08042301724TR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 17mm height, 24 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301720TR1

42 X 30 X 17mm, 20 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423017-20TR
In Commercial Distribution

  • M697T08042301720TR0 ()
  • M697T08042301720TR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 17mm height, 20 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301524TR1

42 X 30 X 15mm, 24 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423015-24TR
In Commercial Distribution

  • M697T08042301524TR0 ()
  • M697T08042301524TR1 ()

  • 30mm depth X 15mm height, 24 DEG TRIAL
  • Width: 42 Millimeter


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301520TR1

42 X 30 X 15mm, 20 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423015-20TR
In Commercial Distribution

  • M697T08042301520TR0 ()
  • M697T08042301520TR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 15mm height, 20 DEG TRIAL


  • Spinal implant trial

X90 Pedicle Screw System - M697N60001036DL1

Assembly, X90 4.75 x 30 DUAL LEAD SCREW
Xtant Medical Holdings, Inc.
N60001036-DL
In Commercial Distribution

  • M697N60001036DL1 ()

  • Length: 30 Millimeter
  • Outer Diameter: 4.75 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

GFS - M685100560

Large Graft Fixation System, 30 mm Suture Loop
PARCUS MEDICAL LLC
10056
In Commercial Distribution

  • M685100560 ()

  • 30 mm Suture Loop
10056

  • Tendon/ligament bone anchor, non-bioabsorbable
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