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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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VISICOIL - EIBAVC110020PL0

1.10mm x 2.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-110-020-PL
In Commercial Distribution

  • EIBAVC110020PL0 ()
VC-110-020-PL

  • Radiological image marker, implantable

VISICOIL - EIBAVC110010PL0

1.10mm x 1.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-110-010-PL
In Commercial Distribution

  • EIBAVC110010PL0 ()
VC-110-010-PL

  • Radiological image marker, implantable

VISICOIL - EIBAVC075020PL300

0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-075-020-PL30
In Commercial Distribution

  • EIBAVC075020PL300 ()
VC-075-020-PL30

  • Radiological image marker, implantable

VISICOIL - EIBAVC075010PL0

0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-075-010-PL
In Commercial Distribution

  • EIBAVC075010PL0 ()
VC-075-010-PL

  • Radiological image marker, implantable

VISICOIL - EIBAVC075005PL120

0.75mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-075-005-PL12
In Commercial Distribution

  • EIBAVC075005PL120 ()
VC-075-005-PL12

  • Radiological image marker, implantable

VISICOIL - EIBAVC050020PLSL0

0.50mm x 2.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-050-020-PLSL
In Commercial Distribution

  • EIBAVC050020PLSL0 ()
VC-050-020-PLSL

  • Radiological image marker, implantable

VISICOIL - EIBAVC050010PLSL0

0.5mm x 1.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-050-010-PLSL
In Commercial Distribution

  • EIBAVC050010PLSL0 ()
VC-050-010-PLSL

  • Radiological image marker, implantable

VISICOIL - EIBAVC050010PL0

0.50mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-050-010-PL
In Commercial Distribution

  • EIBAVC050010PL0 ()
VC-050-010-PL

  • Radiological image marker, implantable

VISICOIL - EIBAVC050005PL300

0.50mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-050-005-PL30
In Commercial Distribution

  • EIBAVC050005PL300 ()
VC-050-005-PL30

  • Radiological image marker, implantable

KOALA - 09120105730464

The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.
IB Lab GmbH
V2.11
Not in Commercial Distribution

  • 09120105730471 ()
  • 09120105730464 ()


  • X-ray image interpretive software
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