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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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Monarch™ Software Laptop v2.1.5 - B634SW0032760201050

Monarch™ Software Laptop v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032760201050 ()


  • CT system application software

Monarch™ Software Laptop v2.1.4 - B634SW0032760201040

Monarch™ Software Laptop v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution

  • B634SW0032760201040 ()


  • CT system application software

Monarch™ Software Laptop v2.1.3 - B634SW0032760201030

Monarch™ Software Laptop v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution

  • B634SW0032760201030 ()


  • CT system application software

Monarch™ Software Laptop v2.1.2 - B634SW0032760201020

Monarch™ Software Laptop v2.1.2
AURIS HEALTH, INC.
Version 2.1.2
In Commercial Distribution

  • B634SW0032760201020 ()


  • CT system application software

vascuCAP - B745VASCUCAPA2

No Description
ELUCID BIOIMAGING INC.
A.2
In Commercial Distribution

  • B745VASCUCAPA2 ()


  • CT system application software

ElucidVivo - B745ELUCIDVIVOA3

No Description
ELUCID BIOIMAGING INC.
A.3
In Commercial Distribution

  • B745ELUCIDVIVOA3 ()


  • CT system application software

vascuCAP - B745A40

No Description
ELUCID BIOIMAGING INC.
A.1.2
In Commercial Distribution

  • B745A40 ()


  • CT system application software

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

N/A - 10705036012412

Endoscopic Curved Intraluminal Stapler (ILS) 28 Titanium Adjustable Height Staples
ETHICON ENDO-SURGERY, LLC
ECS33A
In Commercial Distribution

  • 10705036012412 ()
  • 20705036012419 ()
ECS33A

  • Intraluminal circular stapler, single-use

N/A - 10705036003540

Straight Intraluminal Slapler (ILS) 28Titanium Adjustable Height Staples
ETHICON ENDO-SURGERY, LLC
SDH33A
In Commercial Distribution

  • 10705036003540 ()
  • 20705036003547 ()
SDH33A

  • Intraluminal circular stapler, single-use
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