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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 - M697C06600981

SPECIALTY 5MM IRIX-C GUIDED MODULAR INSERTER TIP W/O STOPS
Xtant Medical Holdings, Inc.
C066-0098
In Commercial Distribution

  • M697C06600980 ()
  • M697C06600981 ()

  • Height: 5 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697C06600901

SPECIALTY 5MM IRIX-C PARALLEL RASP ASSY W/O STOPS
Xtant Medical Holdings, Inc.
C066-0090
In Commercial Distribution

  • M697C06600900 ()
  • M697C06600901 ()

  • Height: 5 Millimeter


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697C03402241

SPECIALTY 5mm PADDLE SHAVER
Xtant Medical Holdings, Inc.
C034-0224
In Commercial Distribution

  • M697C03402240 ()
  • M697C03402241 ()

  • Height: 5 Millimeter


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697C03402181

5 MM, SPECIALTY PLIF LOLLIPOP RASP W/ TEE HANDLE ASSEMBLY.
Xtant Medical Holdings, Inc.
C034-0218
In Commercial Distribution

  • M697C03402180 ()
  • M697C03402181 ()

  • Height: 5 Millimeter


  • Polymeric spinal interbody fusion cage

ZenithDental Type-T High Copper Spherical - D033099610061

ZenithDental Type-T High Copper Spherical Dental Alloy Tablets Micro Fast Set 5Toz
DMG AMERICA, LLC
61006
In Commercial Distribution

  • D033099610061 ()
  • D033099610060 ()

  • Weight: 5 Gram
099-61006

  • Dental amalgam

ZenithDental Premium Dispersed Phase - D033099610051

ZenithDental Premium Dispersed Phase Dental Alloy Tablets Fast Set 5Toz
DMG AMERICA, LLC
61005
In Commercial Distribution

  • D033099610051 ()
  • D033099610050 ()

  • Weight: 5 Gram
099-61005

  • Dental amalgam

ZenithDental Premium Dispersed Phase - D033099610041

ZenithDental Premium Dispersed Phase Dental Alloy Tablets Regular Set 5Toz
DMG AMERICA, LLC
61004
In Commercial Distribution

  • D033099610041 ()
  • D033099610040 ()

  • Weight: 5 Gram
099-61004

  • Dental amalgam

ZenithDental Type-T High Copper Spherical - D033099610021

ZenithDental Type-T High Copper Spherical Dental Alloy Powder Micro Fast Set 5Toz
DMG AMERICA, LLC
61002
In Commercial Distribution

  • D033099610021 ()
  • D033099610020 ()

  • Weight: 5 Gram
099-61002

  • Dental amalgam

ZenithDental Premium Dispersed Phase - D033099610011

ZenithDental Premium Dispersed Phase Dental Alloy Powder Fast Set 5Toz
DMG AMERICA, LLC
61001
In Commercial Distribution

  • D033099610011 ()
  • D033099610010 ()

  • Weight: 5 Gram
099-61001

  • Dental amalgam

ZenithDental Premium Dispersed Phase - D033099600001

ZenithDental Premium Dispersed Phase Dental Alloy Powder Regular Set 5Toz
DMG AMERICA, LLC
60000
In Commercial Distribution

  • D033099600001 ()
  • D033099600000 ()

  • Weight: 5 Gram
099-60000

  • Dental amalgam
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