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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-C Cervical Integrated Fusion System - M697C06601281

Specialty 60 Degree Awl with retractable Sleeve
Xtant Medical Holdings, Inc.
C066-0128
In Commercial Distribution

  • M697C06601280 ()
  • M697C06601281 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697C06601271

Specialty 45 Degree Awl with retractable Sleeve
Xtant Medical Holdings, Inc.
C066-0127
In Commercial Distribution

  • M697C06601270 ()
  • M697C06601271 ()


  • Polymeric spinal interbody fusion cage

NA - 10887587056128

TI ALVEOLAR DISTRACTOR WITH STRAIGHT PLATE 16MM
Synthes GmbH
488.076
In Commercial Distribution

  • 10887587056128 ()
  • H9804880760 ()
488076

  • Implantable craniofacial bone distractor

NA - 10887587056111

TI ALVEOLAR DISTRACTOR WITH STRAIGHT PLATE 12MM
Synthes GmbH
488.075
In Commercial Distribution

  • 10887587056111 ()
  • H9804880750 ()
488075

  • Implantable craniofacial bone distractor

NA - 10887587056104

TI ALVEOLAR DISTRACTOR WITH STRAIGHT PLATE 8MM
Synthes GmbH
488.074
In Commercial Distribution

  • 10887587056104 ()
  • H9804880740 ()
488074

  • Implantable craniofacial bone distractor

NA - 10887587054612

TI LOCKING RECONSTRUCTION PLATE WITH ANGLE-4X4 HOLES
Synthes GmbH
449.653
In Commercial Distribution

  • H9804496530 ()
  • 10887587054612 ()
449653

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

NA - 10887587054605

TI LOCKING RECONSTRUCTION PLATE WITH ANGLE-3X3 HOLES
Synthes GmbH
449.652
In Commercial Distribution

  • H9804496520 ()
  • 10887587054605 ()
449652

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AVANOS - 00350770429601

MIC-KEY* SF Patient Starter Kit with ENFit*
Avanos Medical, Inc.
7148-00
In Commercial Distribution

  • 10350770429608 ()
  • 00350770429601 ()
7148-00

  • Gastrostomy button

Zavation - 00197157006150

Sizer with One Stop/0deg/11&12mm
Zavation LLC
ZAV-1333-12
In Commercial Distribution

  • 00197157006150 ()


  • Spinal fixation plate, non-bioabsorbable

Zavation - 00197157006143

Sizer with One Stop/0deg/9&10mm
Zavation LLC
ZAV-1333-11
In Commercial Distribution

  • 00197157006143 ()


  • Spinal fixation plate, non-bioabsorbable
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