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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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LINK Endo-Model EVO Knee System - 04026575274772

Replacement set, CoCrMo, UHMWPE, Ti6Al4V, for LINK Endo-Model EVO, pure hinge with security screw (EVO)
WALDEMAR LINK GmbH & Co. KG
15-0037/27
In Commercial Distribution

  • 04026575274772 ()


  • Rotating hinged total knee prosthesis

LINK Instruments - Trial implants and size gauges - 04026575306800

Orthopaedic prosthesis instrument, reusable - General Instrument
WALDEMAR LINK GmbH & Co. KG
99-0090/27
In Commercial Distribution

  • 04026575306800 ()


  • Femoral stem prosthesis trial

LINK Instruments - Trial implants and size gauges - 04026575409730

Femoral stem prosthesis trial - General Instrument
WALDEMAR LINK GmbH & Co. KG
99-0984/27
In Commercial Distribution

  • 04026575409730 ()


  • Femoral stem prosthesis trial

LINK Embrace Shoulder System Line Extension - 04026575439614

Glenoid orthopaedic reamer - LINK Embrace Shoulder System
WALDEMAR LINK GmbH & Co. KG
645-001/27
In Commercial Distribution

  • 04026575439614 ()


  • Glenoid orthopaedic reamer

LINK Endo-Model EVO Knee System - 04026575184200

Femoral segment, uncemented, CoCrMo, Ti6Al4V, L-shaped for rotating hinge and pure hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-2710/27
In Commercial Distribution

  • 04026575184200 ()


  • Knee arthroplasty wedge

ChekMate™ Strips - 00381930860019

ChekMate™ Strips are dry strips that mimic the use of the PTS Panels test strips to check the CardioChek analyzer system optics, calibration, and result handling algorithms.
POLYMER TECHNOLOGY SYSTEMS, INC.
860
Not in Commercial Distribution

  • 00381930860019 ()
  • 10381930860016 ()
860

  • Glucose/ketone/lipid profile IVD, calibrator

GUTTA PERCHA POINTS - 08806383553810

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383553810 ()
C101-S693

  • Natural gutta-percha

GUTTA PERCHA POINTS - 08806383552738

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383552738 ()
171-298

  • Natural gutta-percha

MM MARKED GUTTA PERCHA POINTS - 08806383548502

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
DIA-PROISO-.06 PLUS 90
In Commercial Distribution

  • 08806383548502 ()
ML159-S615

  • Natural gutta-percha

ABSORBENT PAPER POINTS - 08806383551502

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
ISO ASST 90/140
In Commercial Distribution

  • 08806383551502 ()
C201-S693

  • Endodontic paper point
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