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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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MEDENTiKA - EMKAB60LET9

Laboratory screw
MEDENTiKA GmbH
B 60 L-ET
In Commercial Distribution

  • 04251574837592 ()
  • EMKAB60LET9 ()

  • compatible with Bredent Medical / SKY®*
B 60 L-ET

  • Dental prosthesis/implant abutment screw analog, reusable

MEDENTiKA - EMKAB60L9

Laboratory screw
MEDENTiKA GmbH
B 60 L
In Commercial Distribution

  • 04251574806239 ()
  • EMKAB60L9 ()

  • compatible with Bredent Medical / SKY®*
B 60 L

  • Dental prosthesis/implant abutment screw analog, reusable

MEDENTiKA - EMKAB509

Laboratory implant
MEDENTiKA GmbH
B 50
In Commercial Distribution

  • 04251574806215 ()
  • EMKAB509 ()

  • compatible with Bredent Medical / SKY®*
B 50

  • Dental implant analog

MEDENTiKA - EMKAB49009

MedentiBASE Scanbody
MEDENTiKA GmbH
B 4900
In Commercial Distribution

  • 04251574806208 ()
  • EMKAB49009 ()

  • compatible with Bredent Medical / SKY®*
B 4900

  • Dental implant suprastructure, temporary, preformed, reusable

MEDENTiKA - EMKAB46209

MedentiBASE implant pick-up
MEDENTiKA GmbH
B 4620
In Commercial Distribution

  • 04251574806116 ()
  • EMKAB46209 ()

  • compatible with Bredent Medical / SKY®*
B 4620

  • Dental implant suprastructure, temporary, preformed, reusable

MEDENTiKA - EMKAB40RT9

Guide sleeve
MEDENTiKA GmbH
B 40 RT
In Commercial Distribution

  • 04251574841544 ()
  • EMKAB40RT9 ()

  • compatible with Bredent Medical / SKY®*
B 40 RT

  • Surgical drill guide, single-use

MEDENTiKA - EMKAB40RK9

Drilling sleeve
MEDENTiKA GmbH
B 40 RK
In Commercial Distribution

  • 04251574833723 ()
  • EMKAB40RK9 ()

  • compatible with Bredent Medical / SKY®*
B 40 RK

  • Surgical drill guide, single-use

MEDENTiKA - EMKAB14009

Scanbody
MEDENTiKA GmbH
B 1400
In Commercial Distribution

  • 04251574805928 ()
  • EMKAB14009 ()

  • compatible with Bredent Medical / SKY®*
B 1400

  • Dental implant suprastructure, temporary, preformed, reusable

PleuraFlow® System - 00856449006031

PF-32 PleuraFlow® System
Clearflow, Inc.
PF-32
Not in Commercial Distribution

  • 00856449006031 ()
  • 10856449006038 ()
  • 20856449006035 ()

  • Catheter Gauge: 32 French


  • Closed-wound drain, non-bioabsorbable
  • Mediastinal drainage catheter, non-antimicrobial
  • Pleural catheter

PleuraFlow® System - 00856449006024

PF-28 PleuraFlow® System
Clearflow, Inc.
PF-28
Not in Commercial Distribution

  • 10856449006021 ()
  • 00856449006024 ()
  • 20856449006028 ()

  • Catheter Gauge: 28 French


  • Closed-wound drain, non-bioabsorbable
  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial
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