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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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SurgiCase Planner
Materialise NV
SurgiCase Planner
Not in Commercial Distribution

  • E314SURGICASEPLANNER0 ()
SurgiCase Planner

  • CAD/CAM software
SurgiCase OOS
Materialise NV
SurgiCase OOS
In Commercial Distribution

  • E314SURGICASEOOS0 ()
SurgiCase OOS

  • CAD/CAM software
SurgiCase Online
Materialise NV
SurgiCase Online
In Commercial Distribution

  • E314SURGICASEONLINE0 ()
SurgiCase Online

  • CAD/CAM software
SurgiCase Knee Planner
Materialise NV
SurgiCase Knee Planner
In Commercial Distribution

  • E314SURGICASEKNEEPLAN0 ()
SurgiCase Knee Planner

  • CAD/CAM software
SurgiCase Connect (iPad)
Materialise NV
SurgiCase Connect
Not in Commercial Distribution

  • E314SURGICASECONNECTIP0 ()
SurgiCase Connect

  • CAD/CAM software
SurgiCase Connect
Materialise NV
SurgiCase Connect
Not in Commercial Distribution

  • E314SURGICASECONNECT0 ()
SurgiCase Connect

  • CAD/CAM software
SurgiCase CMF
Materialise NV
SurgiCase CMF
Not in Commercial Distribution

  • E314SURGICASECMF0 ()
SurgiCase CMF

  • CAD/CAM software
Signature online management system
Materialise NV
Signature online management system
Not in Commercial Distribution

  • E314SIGNATUREOMS0 ()
Signature online management system

  • CAD/CAM software
Signature Planner
Materialise NV
Signature Planner
Not in Commercial Distribution

  • E314SIGNATURE0 ()
Signature Planner

  • CAD/CAM software
ProPlan CMF Online
Materialise NV
ProPlan CMF Online
In Commercial Distribution

  • E314PROPLANCMFONLINE0 ()
ProPlan CMF Online

  • CAD/CAM software
ProPlan CMF Connect
Materialise NV
ProPlan CMF Connect
Not in Commercial Distribution

  • E314PROPLANCMFCONNECT0 ()
ProPlan CMF Connect

  • CAD/CAM software
ProPlan CMF
Materialise NV
ProPlan CMF
In Commercial Distribution

  • E314PROPLANCMF0 ()
ProPlan CMF

  • CAD/CAM software
Mimics Medical
Materialise NV
Mimics Medical
In Commercial Distribution

  • E314MIMICSMEDICAL0 ()
Mimics Medical

  • CAD/CAM software
Mimics inPrint
Materialise NV
Mimics inPrint
In Commercial Distribution

  • E314MIMICSINPRINT0 ()
Mimics inPrint

  • CAD/CAM software
Mimics Enlight Medical
Materialise NV
Mimics Enlight Medical
In Commercial Distribution

  • E314MIMICSENLIGHTMED0 ()
Mimics Enlight Medical

  • CAD/CAM software
Mimics Automatic Algorithms Knee MRI
Materialise NV
Knee MRI
In Commercial Distribution

  • E314MIMICSAAKNEEMRI0 ()
Knee MRI

  • CAD/CAM software
Mimics Automatic Algorithms Knee CT
Materialise NV
Knee CT
In Commercial Distribution

  • E314MIMICSAAKNEECT0 ()
Knee CT

  • CAD/CAM software
Mimics Automatic Algorithms Heart CT
Materialise NV
Heart CT
In Commercial Distribution

  • E314MIMICSAAHEARTCT0 ()
Heart CT

  • CAD/CAM software
Mimics Automatic Algorithms CMF CT
Materialise NV
CMF CT
Not in Commercial Distribution

  • E314MIMICSAACMFCT0 ()
CMF CT

  • CAD/CAM software
3-matic Medical
Materialise NV
3-matic Medical
In Commercial Distribution

  • E3143MATICMEDICAL0 ()
3-matic Medical

  • CAD/CAM software
3-matic Medical
Materialise NV
3-matic Medical
Not in Commercial Distribution

  • E31433MATICMEDICAL0 ()
3-matic Medical

  • CAD/CAM software
Sidexis 4 (Update) 4.4
SIRONA Dental Systems GmbH
6775592
In Commercial Distribution

  • E27667755921 ()


  • Radiological PACS software
Sidexis 4 (Upgrade) 4.4
SIRONA Dental Systems GmbH
6775584
In Commercial Distribution

  • E27667755841 ()


  • Radiological PACS software
Sidexis 4 (Full version) 4.4
SIRONA Dental Systems GmbH
6773787
In Commercial Distribution

  • E27667737871 ()


  • Radiological PACS software
Sidexis 4 V4.4
SIRONA Dental Systems GmbH
6773258
In Commercial Distribution

  • E27667732580 ()


  • Radiological PACS software
CEREC AC 2.0 with Omnicam camera and touch pad
SIRONA Dental Systems GmbH
6667237
In Commercial Distribution

  • E27666672370 ()


  • CAD/CAM software
CEREC AC 2.0 with QCC camera and touch pad
SIRONA Dental Systems GmbH
6667211
In Commercial Distribution

  • E27666672110 ()


  • CAD/CAM software
Sidexis 4 Basis-DVD
SIRONA Dental Systems GmbH
6663277
In Commercial Distribution

  • E27666632770 ()


  • Radiological PACS software
Sidexis Update
SIRONA Dental Systems GmbH
6618263
In Commercial Distribution

  • E27666182630 ()


  • Radiological PACS software
Sidexis 4 Basis-DVD
SIRONA Dental Systems GmbH
6616465
In Commercial Distribution



  • Radiological PACS software
CEREC SW 4.4.1
SIRONA Dental Systems GmbH
6580265
In Commercial Distribution

  • E27665802650 ()


  • CAD/CAM software
CEREC Premium CAM SW 4.4.0
SIRONA Dental Systems GmbH
6574250
In Commercial Distribution

  • E27665742500 ()


  • CAD/CAM software
CEREC AF Connect with Omnicam
SIRONA Dental Systems GmbH
6564715
In Commercial Distribution

  • E27665647150 ()


  • CAD/CAM software
CEREC AI Connect with Omnicam
SIRONA Dental Systems GmbH
6564707
In Commercial Distribution

  • E27665647070 ()


  • CAD/CAM software
CEREC Ortho SW 1.1
SIRONA Dental Systems GmbH
6562107
Not in Commercial Distribution

  • E27665621070 ()


  • CAD/CAM software
inLab CAM 15.0
SIRONA Dental Systems GmbH
6553882
In Commercial Distribution

  • E27665538820 ()


  • CAD/CAM software
inLab SW 15.0
SIRONA Dental Systems GmbH
6553874
In Commercial Distribution

  • E27665538740 ()


  • CAD/CAM software
CEREC Premium SW 4.4.0
SIRONA Dental Systems GmbH
6553031
In Commercial Distribution

  • E27665530310 ()


  • CAD/CAM software
CEREC SW 4.4
SIRONA Dental Systems GmbH
6553023
In Commercial Distribution

  • E27665530230 ()


  • CAD/CAM software
inCoris PMMA guide disc 22
SIRONA Dental Systems GmbH
6551324
In Commercial Distribution

  • E27665513242 ()


  • CAD/CAM software
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