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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CC/ Opaque Modifier OM-16 ocker 15g
KLEMA Dentalprodukte GmbH
001516
In Commercial Distribution

  • ECWG0015161 ()
001516

  • Dental appliance fabrication material, ceramic
CC/ Pearl Enamel PS-1 blue/white
KLEMA Dentalprodukte GmbH
000582
In Commercial Distribution

  • ECWG0005821 ()
000582

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-06 heavy orange
KLEMA Dentalprodukte GmbH
000570
In Commercial Distribution

  • ECWG0005701 ()
000570

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-05 medium orange
KLEMA Dentalprodukte GmbH
000569
In Commercial Distribution

  • ECWG0005691 ()
000569

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-04 light orange
KLEMA Dentalprodukte GmbH
000568
In Commercial Distribution

  • ECWG0005681 ()
000568

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-03 heavy yellow
KLEMA Dentalprodukte GmbH
000567
In Commercial Distribution

  • ECWG0005671 ()
000567

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-02 medium yellow
KLEMA Dentalprodukte GmbH
000566
In Commercial Distribution

  • ECWG0005661 ()
000566

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-01 light yellow
KLEMA Dentalprodukte GmbH
000565
In Commercial Distribution

  • ECWG0005651 ()
000565

  • Dental appliance fabrication material, ceramic
CC/ Creapast IO gold yellow 3g
KLEMA Dentalprodukte GmbH
000320
In Commercial Distribution

  • ECWG0003201 ()
000320

  • Dental appliance fabrication material, ceramic
CC/ Pearl Enamel PS-1 blue/white
KLEMA Dentalprodukte GmbH
000282
In Commercial Distribution

  • ECWG0002821 ()
000282

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-04 light orange
KLEMA Dentalprodukte GmbH
000268
In Commercial Distribution

  • ECWG0002681 ()
000268

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-03 heavy yellow
KLEMA Dentalprodukte GmbH
000267
In Commercial Distribution

  • ECWG0002671 ()
000267

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-02 medium yellow
KLEMA Dentalprodukte GmbH
000266
In Commercial Distribution

  • ECWG0002661 ()
000266

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-01 light yellow
KLEMA Dentalprodukte GmbH
000265
In Commercial Distribution

  • ECWG0002651 ()
000265

  • Dental appliance fabrication material, ceramic
CC/ Bleach Kit (incl. shade guide)
KLEMA Dentalprodukte GmbH
000250
In Commercial Distribution

  • ECWG0002501 ()
000250

  • Dental appliance fabrication material, ceramic
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 Evacuator 50 cc With Adapter
Gyrus ACMI, LLC
188A
In Commercial Distribution

  • 00821925001077 ()


  • Bladder evacuator, reusable
Toomey Evacuator 30 cc, With Adapter
Gyrus ACMI, LLC
188
In Commercial Distribution

  • 00821925001053 ()


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

  • 00889813009802 ()
  • 00889813009796 ()
9512827

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

  • 00889813007334 ()
  • 00889813007327 ()
9512829

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

  • 00889813007310 ()
  • 00889813007303 ()
9512825

  • Endodontic reamer
PHILIPS CC TABLE PAD CONTOUR FOAM
AADCO MEDICAL, INC.
TP-910
In Commercial Distribution

  • 00840348511055 ()
TP-910

  • Freestanding patient positioner, reusable
CC/ Gingiva G6 dark pink opaque
KLEMA Dentalprodukte GmbH
001596
In Commercial Distribution

  • 09010782023013 ()
001596

  • Dental appliance fabrication material, ceramic
CC/ Approx. Dentine AD-1 light yellow
KLEMA Dentalprodukte GmbH
001568
In Commercial Distribution

  • 09010782022788 ()
001568

  • Dental appliance fabrication material, ceramic
CC/ Pearl Enamel PS-1 blue/white
KLEMA Dentalprodukte GmbH
000282
In Commercial Distribution

  • 09010782020784 ()
000282

  • Dental appliance fabrication material, ceramic
CC/ Bleach Kit (incl. shade guide)
KLEMA Dentalprodukte GmbH
000250
In Commercial Distribution

  • 09010782001554 ()
000250

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-04 light orange
KLEMA Dentalprodukte GmbH
000568
In Commercial Distribution

  • 09010782021583 ()
000568

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-03 heavy yellow
KLEMA Dentalprodukte GmbH
000567
In Commercial Distribution

  • 09010782021576 ()
000567

  • Dental appliance fabrication material, ceramic
CC/ Effect Enamel SI-02 medium yellow
KLEMA Dentalprodukte GmbH
000566
In Commercial Distribution

  • 09010782021569 ()
000566

  • Dental appliance fabrication material, ceramic
CC/ Gingiva Kit (incl. shade guide)
KLEMA Dentalprodukte GmbH
001590
In Commercial Distribution

  • 09010782004166 ()
001590

  • Dental appliance fabrication material, ceramic
SCREW 54840019595 CN MAS 9.5X95 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840019595
In Commercial Distribution

  • 00613994594006 ()

  • Length: 95.0 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840019590 CN MAS 9.5X90 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840019590
In Commercial Distribution

  • 00613994593993 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 90.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840019585 CN MAS 9.5X85 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840019585
In Commercial Distribution

  • 00613994593986 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 85.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840011085 CN MAS 10.0X85 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840011085
In Commercial Distribution

  • 00613994593726 ()

  • Outer Diameter: 10.0 Millimeter
  • Length: 85.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840011500 CN MAS 10.5X100 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840011500
In Commercial Distribution

  • 00613994593696 ()

  • Length: 100.0 Millimeter
  • Outer Diameter: 10.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840011585 CN MAS 10.5X85 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840011585
In Commercial Distribution

  • 00613994593665 ()

  • Outer Diameter: 10.5 Millimeter
  • Length: 85.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840011595 CN MAS 10.5X95 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840011595
In Commercial Distribution

  • 00613994593641 ()

  • Length: 95.0 Millimeter
  • Outer Diameter: 10.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840018035 CN MAS 8.0X35 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840018035
In Commercial Distribution

  • 00613994593580 ()

  • Length: 35.0 Millimeter
  • Outer Diameter: 8.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840018045 CN MAS 8.0X45 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840018045
In Commercial Distribution

  • 00613994593566 ()

  • Outer Diameter: 8.45 Millimeter
  • Length: 45.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840018060 CN MAS 8.0X60 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840018060
In Commercial Distribution

  • 00613994593535 ()

  • Outer Diameter: 8.0 Millimeter
  • Length: 60.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840018070 CN MAS 8.0X70 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840018070
In Commercial Distribution

  • 00613994593511 ()

  • Length: 70.0 Millimeter
  • Outer Diameter: 8.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840018080 CN MAS 8.0X80 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840018080
In Commercial Distribution

  • 00613994593498 ()

  • Outer Diameter: 8.0 Millimeter
  • Length: 80.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840018520 CN MAS 8.5X20 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840018520
In Commercial Distribution

  • 00613994593481 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 20.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840018525 CN MAS 8.5X25 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840018525
In Commercial Distribution

  • 00613994593474 ()

  • Length: 25.0 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840018535 CN MAS 8.5X35 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840018535
In Commercial Distribution

  • 00613994593450 ()

  • Length: 35.0 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840018545 CN MAS 8.5X45 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840018545
In Commercial Distribution

  • 00613994593436 ()

  • Length: 45.0 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840018550 CN MAS 8.5X50 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840018550
In Commercial Distribution

  • 00613994593429 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 50.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840018030 CN MAS 8.0X30 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840018030
In Commercial Distribution

  • 00613994593412 ()

  • Outer Diameter: 8.0 Millimeter
  • Length: 30.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840017520 CN MAS 7.5X20 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840017520
In Commercial Distribution

  • 00613994593405 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 20.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 54840017525 CN MAS 7.5X25 CC
MEDTRONIC SOFAMOR DANEK, INC.
54840017525
In Commercial Distribution

  • 00613994593399 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 25.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
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