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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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NA - 08717213052246

Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170537-06
Not in Commercial Distribution

  • 08717213052246 ()


  • Radiation therapy software

NA - 08717213051843

Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170003-24
Not in Commercial Distribution

  • 08717213051843 ()


  • Radiation therapy software

NA - 08717213051775

Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170003-23
Not in Commercial Distribution

  • 08717213051775 ()


  • Radiation therapy software

Sidexis 4 - E27667755921

Sidexis 4 (Update) 4.4
SIRONA Dental Systems GmbH
6775592
In Commercial Distribution

  • E27667755921 ()


  • Radiological PACS software

Sidexis 4 - E27667755841

Sidexis 4 (Upgrade) 4.4
SIRONA Dental Systems GmbH
6775584
In Commercial Distribution

  • E27667755841 ()


  • Radiological PACS software

Sidexis 4 - E27667737871

Sidexis 4 (Full version) 4.4
SIRONA Dental Systems GmbH
6773787
In Commercial Distribution

  • E27667737871 ()


  • Radiological PACS software

Sidexis 4 - E27667732580

Sidexis 4 V4.4
SIRONA Dental Systems GmbH
6773258
In Commercial Distribution

  • E27667732580 ()


  • Radiological PACS software

CEREC - E27666672370

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

  • E27666672370 ()


  • CAD/CAM software

CEREC - E27666672110

CEREC AC 2.0 with QCC camera and touch pad
SIRONA Dental Systems GmbH
6667211
In Commercial Distribution

  • E27666672110 ()


  • CAD/CAM software

Sidexis 4 - E27666632770

Sidexis 4 Basis-DVD
SIRONA Dental Systems GmbH
6663277
In Commercial Distribution

  • E27666632770 ()


  • Radiological PACS software

Sidexis 4 - E27666182630

Sidexis Update
SIRONA Dental Systems GmbH
6618263
In Commercial Distribution

  • E27666182630 ()


  • Radiological PACS software

Sidexis 4 - E27666164650

Sidexis 4 Basis-DVD
SIRONA Dental Systems GmbH
6616465
In Commercial Distribution



  • Radiological PACS software

CEREC SW - E27665802650

CEREC SW 4.4.1
SIRONA Dental Systems GmbH
6580265
In Commercial Distribution

  • E27665802650 ()


  • CAD/CAM software

CEREC SW - E27665742500

CEREC Premium CAM SW 4.4.0
SIRONA Dental Systems GmbH
6574250
In Commercial Distribution

  • E27665742500 ()


  • CAD/CAM software

CEREC - E27665647150

CEREC AF Connect with Omnicam
SIRONA Dental Systems GmbH
6564715
In Commercial Distribution

  • E27665647150 ()


  • CAD/CAM software

CEREC - E27665647070

CEREC AI Connect with Omnicam
SIRONA Dental Systems GmbH
6564707
In Commercial Distribution

  • E27665647070 ()


  • CAD/CAM software

CEREC SW - E27665621070

CEREC Ortho SW 1.1
SIRONA Dental Systems GmbH
6562107
Not in Commercial Distribution

  • E27665621070 ()


  • CAD/CAM software

CEREC SW - E27665538820

inLab CAM 15.0
SIRONA Dental Systems GmbH
6553882
In Commercial Distribution

  • E27665538820 ()


  • CAD/CAM software

CEREC SW - E27665538740

inLab SW 15.0
SIRONA Dental Systems GmbH
6553874
In Commercial Distribution

  • E27665538740 ()


  • CAD/CAM software

CEREC SW - E27665530310

CEREC Premium SW 4.4.0
SIRONA Dental Systems GmbH
6553031
In Commercial Distribution

  • E27665530310 ()


  • CAD/CAM software

CEREC SW - E27665530230

CEREC SW 4.4
SIRONA Dental Systems GmbH
6553023
In Commercial Distribution

  • E27665530230 ()


  • CAD/CAM software

CEREC Guide - E27665513242

inCoris PMMA guide disc 22
SIRONA Dental Systems GmbH
6551324
In Commercial Distribution

  • E27665513242 ()


  • CAD/CAM software

CEREC - E27665429010

CEREC AI without CEREC Omnicam
SIRONA Dental Systems GmbH
6542901
In Commercial Distribution

  • E27665429010 ()


  • CAD/CAM software

CEREC - E27665428930

CEREC AF without CEREC Omnicam
SIRONA Dental Systems GmbH
6542893
In Commercial Distribution

  • E27665428930 ()


  • CAD/CAM software

CEREC - E27665347910

CEREC AI with CEREC Omnicam
SIRONA Dental Systems GmbH
6534791
In Commercial Distribution

  • E27665347910 ()


  • CAD/CAM software

CEREC - E27665320760

CEREC AF with CEREC Omnicam
SIRONA Dental Systems GmbH
6532076
In Commercial Distribution

  • E27665320760 ()


  • CAD/CAM software

CEREC Guide - E27664665642

CEREC Guide Bloc medi
SIRONA Dental Systems GmbH
6466564
In Commercial Distribution

  • E27664665642 ()


  • CAD/CAM software

CEREC Guide - E27664625632

CEREC Guide Pilot Drill Keys 2.2
SIRONA Dental Systems GmbH
6462563
In Commercial Distribution

  • E27664625632 ()


  • CAD/CAM software

CEREC Guide - E27664625302

CEREC Guide Pilot Drill Keys 2.0
SIRONA Dental Systems GmbH
6462530
In Commercial Distribution

  • E27664625302 ()


  • CAD/CAM software

SIDEXIS 4 - E27664565320

SIDEXIS 4 Basis-DVD
SIRONA Dental Systems GmbH
6456532
In Commercial Distribution

  • E27664565320 ()


  • Radiological PACS software
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