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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 - ECWG0005471

CC/ Dentine D-CW California white
KLEMA Dentalprodukte GmbH
000547
In Commercial Distribution

  • ECWG0005471 ()
000547

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0002851

CC/ Effect Enamel SO-10 blue
KLEMA Dentalprodukte GmbH
000285
In Commercial Distribution

  • ECWG0002851 ()
000285

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0002841

CC/ Pearl Enamel PS-3 orange
KLEMA Dentalprodukte GmbH
000284
In Commercial Distribution

  • ECWG0002841 ()
000284

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0002831

CC/ Pearl Enamel PS-2 flamingo
KLEMA Dentalprodukte GmbH
000283
In Commercial Distribution

  • ECWG0002831 ()
000283

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0002811

CC/ Pearl Enamel PS-0 white
KLEMA Dentalprodukte GmbH
000281
In Commercial Distribution

  • ECWG0002811 ()
000281

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0002561

CC/ Bleach Shoulder SP-AB 15g
KLEMA Dentalprodukte GmbH
000256
In Commercial Distribution

  • ECWG0002561 ()
000256

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0002471

CC/ Dentine D-CW California white
KLEMA Dentalprodukte GmbH
000247
In Commercial Distribution

  • ECWG0002471 ()
000247

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0055931

CC/ Gingiva G3 light pink
KLEMA Dentalprodukte GmbH
005593
In Commercial Distribution

  • ECWG0055931 ()
005593

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0050711

CC/ Opaque Dentine OD-A2 50g
KLEMA Dentalprodukte GmbH
005071
In Commercial Distribution

  • ECWG0050711 ()
005071

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0050691

CC/ Approx. Dentine AD-2 orange
KLEMA Dentalprodukte GmbH
005069
In Commercial Distribution

  • ECWG0050691 ()
005069

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0050561

CC/ Neck Transpa HT-56 ochre
KLEMA Dentalprodukte GmbH
005056
In Commercial Distribution

  • ECWG0050561 ()
005056

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0050541

CC/ Neck Transpa HT-54 honey
KLEMA Dentalprodukte GmbH
005054
In Commercial Distribution

  • ECWG0050541 ()
005054

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0050531

CC/ Neck Transpa HT-53 sand
KLEMA Dentalprodukte GmbH
005053
In Commercial Distribution

  • ECWG0050531 ()
005053

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0050521

CC/ Neck Transpa HT-52 khaki
KLEMA Dentalprodukte GmbH
005052
In Commercial Distribution

  • ECWG0050521 ()
005052

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0050431

CC/ Opaque Dentine OD-43 (ivory)
KLEMA Dentalprodukte GmbH
005043
In Commercial Distribution

  • ECWG0050431 ()
005043

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0050411

CC/ Opaque Dentine OD-41 (D3)
KLEMA Dentalprodukte GmbH
005041
In Commercial Distribution

  • ECWG0050411 ()
005041

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0050371

CC/ Opaque Dentine OD-37 (B4)
KLEMA Dentalprodukte GmbH
005037
In Commercial Distribution

  • ECWG0050371 ()
005037

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0050321

CC/ Opaque Dentine OD-32 (A2-A3)
KLEMA Dentalprodukte GmbH
005032
In Commercial Distribution

  • ECWG0050321 ()
005032

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0050281

CC/ Shoulder SP-28 opac yellow
KLEMA Dentalprodukte GmbH
005028
In Commercial Distribution

  • ECWG0050281 ()
005028

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0050251

CC/ Shoulder SP-25 red brown
KLEMA Dentalprodukte GmbH
005025
In Commercial Distribution

  • ECWG0050251 ()
005025

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0035151

CC/ Transition Dentine TD-D3 50g
KLEMA Dentalprodukte GmbH
003515
In Commercial Distribution

  • ECWG0035151 ()
003515

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0035121

CC/ Transition Dentine TD-C3 50g
KLEMA Dentalprodukte GmbH
003512
In Commercial Distribution

  • ECWG0035121 ()
003512

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0032171

CC/ Transition Dentine TD-BA 20g
KLEMA Dentalprodukte GmbH
003217
In Commercial Distribution

  • ECWG0032171 ()
003217

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0032161

CC/ Transition Dentine TD-D4 20g
KLEMA Dentalprodukte GmbH
003216
In Commercial Distribution

  • ECWG0032161 ()
003216

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0032131

CC/ Transition Dentine TD-C4 20g
KLEMA Dentalprodukte GmbH
003213
In Commercial Distribution

  • ECWG0032131 ()
003213

  • Dental appliance fabrication material, ceramic

Salvo® Spine System - 10840642139952

Connector, Parallel, C-C, Double, Large
Spine Wave, Inc.
11-7406
In Commercial Distribution

  • 10840642139952 ()
11-7406

  • Bone-screw internal spinal fixation system connector

Salvo® Spine System - 10840642139945

Connector, Parallel, C-C, Double, Medium
Spine Wave, Inc.
11-7405
In Commercial Distribution

  • 10840642139945 ()
11-7405

  • Bone-screw internal spinal fixation system connector

Salvo® Spine System - 10840642139938

Connector, Parallel, C-C, Double, Small
Spine Wave, Inc.
11-7404
In Commercial Distribution

  • 10840642139938 ()
11-7404

  • Bone-screw internal spinal fixation system connector

Millennium - 00190776197834

Standard Single Port cc Toomey
Avalign Technologies, Inc.
39-CA3STD4.630TMY
In Commercial Distribution

  • 00190776197834 ()


  • Liposuction system cannula, reusable

Millennium - 00190776197780

Mercedes cc SS Toomey Hub
Avalign Technologies, Inc.
39-CA3MER0320TMY
In Commercial Distribution

  • 00190776197780 ()


  • Liposuction system cannula, reusable

Millennium - 00190776197766

Cannula Las Vegas cc Toomey
Avalign Technologies, Inc.
39-CA3LV3.730TMY
In Commercial Distribution

  • 00190776197766 ()


  • Liposuction system cannula, reusable

General Instruments - 00840180537251

INSIGNIA CC DS GUIDE, SP
ALPHATEC SPINE, INC.
CI-11783-CC15
In Commercial Distribution

  • 00840180537251 ()


  • Surgical drill guide, reusable

General Instruments - 00840180536407

INSIGNIA CC VA DS GUIDE
ALPHATEC SPINE, INC.
CI-11753-CC
In Commercial Distribution

  • 00840180536407 ()


  • Surgical drill guide, reusable

General Instrument - 00840180511718

Modular OCT Screw Tip, CC
ALPHATEC SPINE, INC.
CI-11087-CC
In Commercial Distribution

  • 00840180511718 ()


  • Surgical implant handling forceps

PASS LP SPINAL SYSTEM - 03613720294597

ROD B02223645 D-ROD CC 6X450MM
MEDICREA INTERNATIONAL
B02223645
In Commercial Distribution

  • 03613720294597 ()


  • Bone-screw internal spinal fixation system rod

QLRAD - 08719326258201

RectalPro75 with 100 cc Syringe
QLRAD INTERNATIONAL LTD
105.1014
In Commercial Distribution

  • 08719326258218 ()
  • 08719326258201 ()
  • 08719326258225 ()
  • 08719326258232 ()
  • 08719326258249 ()


  • Prostate immobilization balloon catheter

AoN Implants - 00840192717016

OverDLock - h.6 mm. - CC
FAICO MEDICAL LLC
ALK000600000C
Not in Commercial Distribution

  • 00840192717016 ()


  • Dental implant system

AoN Implants - 00840192717009

OverDLock - h.5 mm. - CC
FAICO MEDICAL LLC
ALK000500000C
Not in Commercial Distribution

  • 00840192717009 ()


  • Dental implant system

AoN Implants - 00840192716996

OverDLock - h.4 mm. - CC
FAICO MEDICAL LLC
ALK000400000C
Not in Commercial Distribution

  • 00840192716996 ()


  • Dental implant system

AoN Implants - 00840192716989

OverDLock - h.3 mm. - CC
FAICO MEDICAL LLC
ALK000300000C
Not in Commercial Distribution

  • 00840192716989 ()


  • Dental implant system

AoN Implants - 00840192716972

OverDLock - h.2 mm. - CC
FAICO MEDICAL LLC
ALK000200000C
Not in Commercial Distribution

  • 00840192716972 ()


  • Dental implant system

AoN Implants - 00840192716965

OverDLock - h.1 mm. - CC
FAICO MEDICAL LLC
ALK000100000C
Not in Commercial Distribution

  • 00840192716965 ()


  • Dental implant system

AoN Implants - 00840192701565

2 pieces Transfer - Short - CC
FAICO MEDICAL LLC
ATR00SHOSN00C
Not in Commercial Distribution

  • 00840192701565 ()


  • Dental implant system

AoN Implants - 00840192701558

2 pieces Transfer - Long - CC
FAICO MEDICAL LLC
ATR00LNGSN00C
Not in Commercial Distribution

  • 00840192701558 ()


  • Dental implant system

AoN Implants - 00840192701527

Transfer - h.9 mm. - CC
FAICO MEDICAL LLC
ATR00SHOIP00C
Not in Commercial Distribution

  • 00840192701527 ()


  • Dental implant system

AoN Implants - 00840192701510

Transfer - h.12 mm. - CC
FAICO MEDICAL LLC
ATR00000IP00C
Not in Commercial Distribution

  • 00840192701510 ()


  • Dental implant system

Intervertebral Disc Preparation Instruments - 00190376394411

LIF, RASP, CC OFFSET, 22MM
ALPHATEC SPINE, INC.
256-16-100-22
In Commercial Distribution

  • 00190376394411 ()


  • Bone file/rasp, manual, reusable

Intervertebral Disc Preparation Instruments - 00190376394404

LIF, RASP, CC OFFSET, 20MM
ALPHATEC SPINE, INC.
256-16-100-20
In Commercial Distribution

  • 00190376394404 ()


  • Bone file/rasp, manual, reusable

Intervertebral Disc Preparation Instruments - 00190376394398

LIF, RASP, CC OFFSET, 18MM
ALPHATEC SPINE, INC.
256-16-100-18
In Commercial Distribution

  • 00190376394398 ()


  • Bone file/rasp, manual, reusable

Intervertebral Disc Preparation Instruments - 00190376394381

LIF, RASP, CC OFFSET, 16MM
ALPHATEC SPINE, INC.
256-16-100-16
In Commercial Distribution

  • 00190376394381 ()


  • Bone file/rasp, manual, reusable
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