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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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Cortera Spinal Fixation System - 00840311252145

Case ASM, IMP, CC Cann, 4.5
Xtant Medical Holdings, Inc.
1509-200150
In Commercial Distribution

  • 00840311252145 ()


  • Instrument tray, 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 - 00840180539538

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

  • 00840180539538 ()


  • Surgical retraction system, reusable

IdentiTi II - 00190376635439

ID II LIF Inserter Sleeve, C-C
ALPHATEC SPINE, INC.
801-140-50
In Commercial Distribution

  • 00190376635439 ()


  • Orthopaedic inorganic implant inserter/extractor, 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

AoN Implants - 00840192716446

Ratchet Extraction Key (OUT) - Short - CC
FAICO MEDICAL LLC
AST00SHOEMCRC
Not in Commercial Distribution

  • 00840192716446 ()


  • Dental implant system

AoN Implants - 00840192716439

Ratchet Activation Key (IN) - Short - CC
FAICO MEDICAL LLC
AST00SHOAMCRC
Not in Commercial Distribution

  • 00840192716439 ()


  • Dental implant system

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

AoN Implants - 00840192702128

Transfer Screw 2 Parts - Short - CC
FAICO MEDICAL LLC
AVR00SHOSN00C
Not in Commercial Distribution

  • 00840192702128 ()


  • Dental implant system

AoN Implants - 00840192702111

Transfer Screw 2 Parts - Long - CC
FAICO MEDICAL LLC
AVR00LNGSN00C
Not in Commercial Distribution

  • 00840192702111 ()


  • Dental implant system

AoN Implants - 00840192701411

Screw Cap h.4 mm. - CC
FAICO MEDICAL LLC
AVT000400000C
Not in Commercial Distribution

  • 00840192701411 ()


  • Dental implant system
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