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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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No Description
Gebr. Brasseler GmbH & Co. KG
GP001A.089.032.M4
In Commercial Distribution

  • 24053613278939 ()
  • 14053613278932 ()
  • E226049440M41 ()
  • 84053613278931 ()
GP001A.089.032 STE

  • Orthopaedic intraoperative positioning pin, single-use
No Description
Gebr. Brasseler GmbH & Co. KG
GP002A.089.032.M4
In Commercial Distribution

  • 24053613278922 ()
  • 14053613278925 ()
  • E226051310M41 ()
  • 84053613278924 ()
GP002A.089.032 STE

  • Orthopaedic intraoperative positioning pin, single-use
No Description
Gebr. Brasseler GmbH & Co. KG
SP-10001-00-00
In Commercial Distribution

  • E226050900MB1 ()
  • 14053613278680 ()
SP-10001-00-00

  • Orthopaedic intraoperative positioning pin, single-use
No Description
Gebr. Brasseler GmbH & Co. KG
SP-10000-00-00
In Commercial Distribution

  • E226050899MB1 ()
  • 14053613278673 ()
SP-10000-00-00

  • Orthopaedic intraoperative positioning pin, single-use
GRADIA® gum Modifier (GM36), 2.4 mL
Gc America Inc.
001905
In Commercial Distribution


  • Total Volume: 2.4 Milliliter
001905

  • Dental composite resin
StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) 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 (L VO) in head CTA images. StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected L VO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow. Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage/ prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.
Circle Cardiovascular Imaging Inc
v2.x
In Commercial Distribution



  • CT system application software
"4AND03 Asian Nasal Dorsum - Straight"
SURGICAL TECHNOLOGY LABORATORIES INC
4AND03
In Commercial Distribution

  • 00850987007178 ()
4AND03

  • Nasal cartilage support implant, non-bioabsorbable
Water-based Personal Lubricant
CC Wellness LLC
41022
In Commercial Distribution

  • B362410220 ()
  • 00851271008048 ()
  • 00851271008031 ()


  • Sexual lubricant
KindKlamp, Penile Clamp, Brazil
ARGENTUM MEDICAL, LLC
20003BR
In Commercial Distribution

  • M45620003BR0 ()
  • 00653599000861 ()


  • Incontinence penis clamp, reusable
Men's Liberty Acute with CathGrip and Towel
ARGENTUM MEDICAL, LLC
BIO2102611
In Commercial Distribution

  • 10653599000851 ()
  • 00653599000854 ()
  • M456BIO21026110 ()


  • Urinary incontinence penis sheath/port, single-use
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