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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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4 FLUTE DRILL, CANNULATED
Xtant Medical Holdings, Inc.
T076-0043
In Commercial Distribution

  • M697T07600430 ()
  • M697T07600431 ()


  • Fluted surgical drill bit, reusable
ACCESS SLEEVE, SHORT
Xtant Medical Holdings, Inc.
T076-0040-3
In Commercial Distribution

  • M697T076004030 ()
  • M697T076004031 ()


  • Orthopaedic implantation sleeve, reusable
ACCESS HEAD
Xtant Medical Holdings, Inc.
T076-0040-2
In Commercial Distribution

  • M697T076004020 ()
  • M697T076004021 ()


  • Orthopaedic implantation sleeve, reusable
ACCESS SLEEVE, LONG
Xtant Medical Holdings, Inc.
T076-0040-1
In Commercial Distribution

  • M697T076004010 ()
  • M697T076004011 ()


  • Orthopaedic implantation sleeve, reusable
ACCESS SLEEVE ASSY, LONG
Xtant Medical Holdings, Inc.
T076-0040
In Commercial Distribution

  • M697T07600400 ()
  • M697T07600401 ()


  • Orthopaedic implantation sleeve, reusable
.062 Sytlet, Cannula Cleaner
Xtant Medical Holdings, Inc.
N60001000
In Commercial Distribution

  • M697N600010000 ()
  • M697N600010001 ()


  • Orthopaedic bone pin, non-bioabsorbable
DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/3 EACH 240 GRAMS LIQUID
ASTRON DENTAL CORPORATION
PCSRSEK1
In Commercial Distribution

  • D810PCSRSEK11 ()
PCSRSEK1

  • Custom-made mouthguard
DENTURE MATERIAL - PACKAGE 160 GRAMS POWDER/120 GRAMS LIQUID
ASTRON DENTAL CORPORATION
PCSRLK1
In Commercial Distribution

  • D810PCSRLK11 ()
PCSRLK1

  • Custom-made mouthguard
DENTURE MATERIAL - PACKAGE 320 GRAMS POWDER / 240 GRAMS LIQUID
ASTRON DENTAL CORPORATION
PCSREK1
In Commercial Distribution

  • D810PCSREK11 ()
PCSREK1

  • Custom-made mouthguard
DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID
ASTRON DENTAL CORPORATION
PCSFSEK1
In Commercial Distribution

  • D810PCSFSEK11 ()
PCSFSEK1

  • Custom-made mouthguard
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