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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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AlloFuse® - M536901380051

AlloFuse® DBM Gel, 5 cc
ALLOSOURCE
90138005
In Commercial Distribution

  • M536901380051 ()

  • 5 cc
90138005

  • Bone matrix implant, human-derived

AlloFuse® - M536901380011

AlloFuse® DBM Gel, 1 cc
ALLOSOURCE
90138001
In Commercial Distribution

  • M536901380011 ()

  • 1 cc
90138001

  • Bone matrix implant, human-derived

AlloFuse® - M536900380101

AlloFuse® DBM Putty, 10 cc
ALLOSOURCE
90038010
In Commercial Distribution

  • M536900380101 ()

  • 10 cc
90038010

  • Bone matrix implant, human-derived

AlloFuse® - M536900380051

AlloFuse® DBM Putty, 5 cc
ALLOSOURCE
90038005
In Commercial Distribution

  • M536900380051 ()

  • 5 cc
90038005

  • Bone matrix implant, human-derived

AlloFuse® - M536900380021

AlloFuse® DBM Putty, 2.5 cc
ALLOSOURCE
90038002
In Commercial Distribution

  • M536900380021 ()

  • 2.5 cc
90038002

  • Bone matrix implant, human-derived

AlloFuse® - M536900380011

AlloFuse® DBM Putty, 1 cc
ALLOSOURCE
90038001
In Commercial Distribution

  • M536900380011 ()

  • 1 cc
90038001

  • Bone matrix implant, human-derived

General Instruments - 00840180539538

Slim Sigma TLIF CC Blade 70mm
ALPHATEC SPINE, INC.
CI-11840-70
In Commercial Distribution

  • 00840180539538 ()


  • Surgical retraction system, reusable

General Instruments - 00840180539545

Slim Sigma TLIF CC Blade 90mm
ALPHATEC SPINE, INC.
CI-11840-90
In Commercial Distribution

  • 00840180539545 ()


  • Surgical retraction system, reusable

General Instruments - 00840180523773

CC DRILL GUIDE - THREAD IN, 24MM
ALPHATEC SPINE, INC.
CI-11444-24
In Commercial Distribution

  • 00840180523773 ()


  • Surgical drill guide, reusable

General Instruments - 00840180523766

CC DRILL GUIDE - THREAD IN, 22MM
ALPHATEC SPINE, INC.
CI-11444-22
In Commercial Distribution

  • 00840180523766 ()


  • Surgical drill guide, reusable

General Instruments - 00840180523759

CC DRILL GUIDE - THREAD IN, 20MM
ALPHATEC SPINE, INC.
CI-11444-20
In Commercial Distribution

  • 00840180523759 ()


  • Surgical drill guide, reusable

General Instruments - 00840180523742

CC DRILL GUIDE - THREAD IN, 18MM
ALPHATEC SPINE, INC.
CI-11444-18
In Commercial Distribution

  • 00840180523742 ()


  • Surgical drill guide, reusable

AoN Implants - 00840192718259

Scanbody Direct Nano Short 3Pod - CC
FAICO MEDICAL LLC
ASBNS00000PPC
Not in Commercial Distribution

  • 00840192718259 ()


  • Dental implant system

Darby Dental Supply, LLC - 00889813009802

REAMERS CC 25MM NO 45 PK6
DARBY DENTAL SUPPLY, LLC
9512827
In Commercial Distribution

  • 00889813009802 ()
  • 00889813009796 ()
9512827

  • Endodontic reamer

Darby Dental Supply, LLC - 00889813007334

REAMERS CC 25MM NO 50 PK6
DARBY DENTAL SUPPLY, LLC
9512829
In Commercial Distribution

  • 00889813007334 ()
  • 00889813007327 ()
9512829

  • Endodontic reamer

Darby Dental Supply, LLC - 00889813007310

REAMERS CC 25MM NO 40 PK6
DARBY DENTAL SUPPLY, LLC
9512825
In Commercial Distribution

  • 00889813007310 ()
  • 00889813007303 ()
9512825

  • Endodontic reamer

Cortera - 00840311203727

Screw, Poly, MIS, CC Cann, 5.5x65
Surgalign Spine Technologies, Inc.
150152-55065
In Commercial Distribution

  • 00840311203727 ()


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

Cortera - 00840311203710

Screw, Poly, MIS, CC Cann, 5.5x60
Xtant Medical Holdings, Inc.
150152-55060
In Commercial Distribution

  • 00840311203710 ()


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

Cortera - 00840311203703

Screw, Poly, MIS, CC Cann, 5.5x55
Xtant Medical Holdings, Inc.
150152-55055
In Commercial Distribution

  • 00840311203703 ()


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

Cortera - 00840311203697

Screw, Poly, MIS, CC Cann, 5.5x50
Xtant Medical Holdings, Inc.
150152-55050
In Commercial Distribution

  • 00840311203697 ()


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