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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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Creation Willi Geller - ECWG0002651

CC/ Effect Enamel SI-01 light yellow
KLEMA Dentalprodukte GmbH
000265
In Commercial Distribution

  • ECWG0002651 ()
000265

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0002501

CC/ Bleach Kit (incl. shade guide)
KLEMA Dentalprodukte GmbH
000250
In Commercial Distribution

  • ECWG0002501 ()
000250

  • Dental appliance fabrication material, ceramic

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

AoN Implants - 00840192701404

Screw Cap h.2 mm. - CC
FAICO MEDICAL LLC
AVT000200000C
Not in Commercial Distribution

  • 00840192701404 ()


  • 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® - M536900380101

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

  • M536900380101 ()

  • 10 cc
90038010

  • 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® - M536901380011

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

  • M536901380011 ()

  • 1 cc
90138001

  • 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® - M536900380011

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

  • M536900380011 ()

  • 1 cc
90038001

  • Bone matrix implant, human-derived

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

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

Sagittae - 00819837021221

Bone Graft Delivery System, 30 cc
SPINEEX, INC.
013-030-11
In Commercial Distribution

  • 00819837021221 ()

  • Total Volume: 30 Milliliter
013-030-11

  • Bone graft funnel

Toomey - 00821925001077

Toomey Evacuator 50 cc With Adapter
Gyrus ACMI, LLC
188A
In Commercial Distribution

  • 00821925001077 ()


  • Bladder evacuator, reusable
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