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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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StrokeSENS - B926SSSX10

StrokeSENS LVO is a radiological computer-aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images.
Circle Neurovascular Imaging Inc
v1.x
In Commercial Distribution

  • B926SSSX10 ()


  • CT system application software

Spectral Color Overlay - 00195278630384

Spectral Color Overlay MD Application Container for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00195278630384 ()
5929649

  • CT system application software

Spectral Bone Marrow - 00195278630377

Spectral Bone Marrow MD Application Container for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00195278630377 ()
5929650

  • CT system application software

Head Auto Views - 00195278629586

Head Auto Views MD Application Container for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00195278629586 ()
5929651

  • CT system application software

DLIR - 00195278620453

SWMD DLIR Application for Smart Subscription
GE HEALTHCARE JAPAN CORPORATION
1.2
In Commercial Distribution

  • 00195278620453 ()
5928863

  • CT system application software

Auto Segmentation - 00195278560384

MD Auto Segmentation for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00195278560384 ()
5919805

  • CT system application software

Spine Auto Views - 00195278534064

Spine Auto Views Medical Device
GE MEDICAL SYSTEMS
See CODE part
In Commercial Distribution

  • 00195278534064 ()


  • CT system application software

SnapShot Freeze 2 - 00195278865335

SnapShot Freeze Medical Device
GE MEDICAL SYSTEMS, INC.
1.1
In Commercial Distribution

  • 00195278865335 ()
5963072

  • CT system application software

EEA OrVil - 10884521042872

Transoral Circular Stapler Anvil Advancing Proximal Guide Suture
Covidien LP
EEAORVIL25A
In Commercial Distribution

  • 20884521042879 ()
  • 10884521042872 ()

  • Outer Diameter: 25 Millimeter
  • Length: 90 Centimeter


  • Intraluminal circular stapler, single-use

EEA OrVil - 10884521042841

Transoral Circular Stapler Anvil
Covidien LP
EEAORVIL21
In Commercial Distribution

  • 20884521042848 ()
  • 10884521042841 ()

  • Outer Diameter: 21 Millimeter


  • Intraluminal circular stapler, single-use
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