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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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Dental Imaging Software - 60889975319575

DENTAL IMAGING SOFTWARE
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution

  • 60889975319575 ()
5319579

  • General-purpose dental x-ray system application software

CS Imaging Suite - 60889975314303

CS IMAGING V7 WINDOWS EDITION
CARESTREAM HEALTH, INC.
CS Imaging Suite
In Commercial Distribution

  • 60889975314303 ()
5314307

  • General-purpose dental x-ray system application software

CS Imaging Software V7 - 60889971745927

CS IMAGING V7 update only
CARESTREAM HEALTH, INC.
CS Imaging Software V7
Not in Commercial Distribution

  • 60889971745927 ()
1745926

  • General-purpose dental x-ray system application software

Dental Imaging Software - 60889971045072

Dental Imaging software update only
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution

  • 60889971045072 ()
1045079

  • General-purpose dental x-ray system application software

VARIANT - B030SPO1530010

Illuminator
CAMBER SPINE TECHNOLOGIES, LLC
SPO-153-001
In Commercial Distribution

  • B030SPO1530010 ()


  • Surgical microscope video camera, non-sterilizable

CPI-3 Clinical Programming Interface - 07630016841552

No Description
Advanced Bionics, LLC
CI-6101
Not in Commercial Distribution

  • 07630016841552 ()


  • Hearing implant implantable-component tester, postoperative

CPI-3 Clinical Programming Interface - 07630016817137

No Description
Advanced Bionics, LLC
CI-6101
Not in Commercial Distribution

  • 07630016817137 ()


  • Hearing implant implantable-component tester, postoperative

Clinician's Programming Interface - 07630016809705

No Description
Advanced Bionics, LLC
AB-6500
Not in Commercial Distribution

  • 07630016809705 ()


  • Hearing implant implantable-component tester, postoperative

QCT PRO Asynchronous 3D Spine and CTXA-Hip System - B052QCTPROM4ASH0

Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 4 Calibration Phantom
MINDWAYS SOFTWARE, INC.
K894854K002113K030330K140342
In Commercial Distribution

  • B052QCTPROM4ASH0 ()
  • QCTPROM4ASHN0100 ()
  • QCTPROM4ASHN0075 ()
  • QCTPROM4ASHN0050 ()
  • QCTPROM4ASHN0025 ()
  • QCTPROM4ASHN0010 ()
  • QCTPROM4ASHN0005 ()
  • QCTPROM4ASHN0003 ()
  • QCTPROM4ASHN0002 ()
  • QCTPROM4ASHN0500 ()
  • QCTPROM4ASHN0200 ()
QCTPROM4ASH

  • CT system application software

QCT PRO Asynchronous 3D Spine and CTXA-Hip System - B052QCTPROM3ASH0

Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 3 QA & Calibration Phantom Set
MINDWAYS SOFTWARE, INC.
K894854K002113K030330K140342
In Commercial Distribution

  • B052QCTPROM3ASH0 ()
QCTPROM3ASH

  • CT system application software
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