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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 - ECWG0015931

CC Gingiva G3 Light pink 15g
KLEMA Dentalprodukte GmbH
001593
In Commercial Distribution

  • ECWG0015931 ()
001593

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0015901

CC/ Gingiva Kit (incl. shade guide)
KLEMA Dentalprodukte GmbH
001590
In Commercial Distribution

  • ECWG0015901 ()
001590

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0015681

CC/ Approx. Dentine AD-1 light yellow
KLEMA Dentalprodukte GmbH
001568
In Commercial Distribution

  • ECWG0015681 ()
001568

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0015651

CC/ Make In MI-65 gold 15g
KLEMA Dentalprodukte GmbH
001565
In Commercial Distribution

  • ECWG0015651 ()
001565

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0015641

CC/ Make In MI-64 flamingo 15g
KLEMA Dentalprodukte GmbH
001564
In Commercial Distribution

  • ECWG0015641 ()
001564

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0015611

CC/ Make In MI-61 ivory 15g
KLEMA Dentalprodukte GmbH
001561
In Commercial Distribution

  • ECWG0015611 ()
001561

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0015441

CC/ Opaque Dentine OD-44 (cuba) 15g
KLEMA Dentalprodukte GmbH
001544
In Commercial Distribution

  • ECWG0015441 ()
001544

  • Dental appliance fabrication material, ceramic

Medicrea|UNiD ROD - 03613720289814

UNID EXP B33245699-01 5.5/6.0 CC
MEDICREA INTERNATIONAL
B33245699-01
In Commercial Distribution

  • 03613720289814 ()


  • Bone-screw internal spinal fixation system rod

Medicrea|UNiD ROD - 03613720289753

UNID EXP B33236099-01 6.0 CC DROD
MEDICREA INTERNATIONAL
B33236099-01
In Commercial Distribution

  • 03613720289753 ()


  • Bone-screw internal spinal fixation system rod

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

AoN Implants - 00840192718259

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

  • 00840192718259 ()


  • 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

AoN Implants - 00840192701404

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

  • 00840192701404 ()


  • Dental implant system

Toomey - 00821925001077

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

  • 00821925001077 ()


  • Bladder evacuator, reusable

Toomey - 00821925001053

Toomey Evacuator 30 cc, With Adapter
Gyrus ACMI, LLC
188
In Commercial Distribution

  • 00821925001053 ()


  • Bladder evacuator, reusable

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

Cortera - 00840311203680

Screw, Poly, MIS, CC Cann, 5.5x45
Xtant Medical Holdings, Inc.
150152-55045
In Commercial Distribution

  • 00840311203680 ()


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

Cortera - 00840311203673

Screw, Poly, MIS, CC Cann, 5.5x40
Xtant Medical Holdings, Inc.
150152-55040
In Commercial Distribution

  • 00840311203673 ()


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

Cortera - 00840311203666

Screw, Poly, MIS, CC Cann, 5.5x35
Xtant Medical Holdings, Inc.
150152-55035
In Commercial Distribution

  • 00840311203666 ()


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

Cortera - 00840311203659

Screw, Poly, MIS, CC Cann, 5.5x30
Xtant Medical Holdings, Inc.
150152-55030
In Commercial Distribution

  • 00840311203659 ()


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

Cortera - 00840311203642

Screw, Poly, MIS, CC Cann, 5.5x25
Xtant Medical Holdings, Inc.
150152-55025
In Commercial Distribution

  • 00840311203642 ()


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

Cortera - 00840311203635

Screw, Poly, MIS, CC Cann, 5.0x120
Surgalign Spine Technologies, Inc.
150152-50120
In Commercial Distribution

  • 00840311203635 ()


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

Cortera - 00840311203628

Screw, Poly, MIS, CC Cann, 5.0x115
Surgalign Spine Technologies, Inc.
150152-50115
In Commercial Distribution

  • 00840311203628 ()


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

Cortera - 00840311203611

Screw, Poly, MIS, CC Cann, 5.0x110
Surgalign Spine Technologies, Inc.
150152-50110
In Commercial Distribution

  • 00840311203611 ()


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