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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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FiberLase - 00860009714939

SS FiberLase GYN LAP-R Handpiece
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
AC-2059620
In Commercial Distribution

  • 00860009714939 ()


  • General/multiple surgical laser system beam guide, reusable

FiberLase - 00860009714922

Cleaning Kit for FiberLase GYN Lap Handpieces
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
AC-1059640
In Commercial Distribution

  • 00860009714922 ()
  • 10860009714929 ()


  • General/multiple surgical laser system beam guide, reusable

FiberLase - 00860009714915

FiberLase GYN LAP-R Handpiece
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
AC-1059620
In Commercial Distribution

  • 00860009714915 ()


  • General/multiple surgical laser system beam guide, reusable

FiberLase - 00860009714908

FiberLase GYN LAP-S Handpiece
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
AC-1059630
In Commercial Distribution

  • 00860009714908 ()


  • General/multiple surgical laser system beam guide, reusable

Flex-Thread Ulna - 00860009697522

Flex-Thread™ Ulna Sterilization Tray
FLOWER ORTHOPEDICS CORPORATION
8816-1
In Commercial Distribution

  • 00860009697522 ()


  • Device sterilization/disinfection container, reusable

Scan Mate® - 00860009411982

No Description
Armor Dental Corp.
40142
In Commercial Distribution

  • 00860009411982 ()


  • Hand-held dental retractor

Scan-Mate® (Blue) - 00860009411920

1
Armor Dental Corp.
40101
In Commercial Distribution

  • 00860009411920 ()


  • Hand-held dental retractor

Scan-Mate® (Black) - 00860009411913

No Description
Armor Dental Corp.
40100
In Commercial Distribution

  • 00860009411913 ()


  • Hand-held dental retractor

Aventus Thrombectomy System - Clot Management System - 00860009303416

The Aventus Clot Management System is connected to the aspiration syringe and is used to filter and return blood to the patient as desired. The clot canister contains a coarse pre-filter to separate blood from clot and is designed to be compatible with off-the-shelf blood transfusion filters.
Inquis Medical, Inc.
IM-0002
In Commercial Distribution

  • 00860009303416 ()


  • Thrombectomy suction catheter

Aventus Thrombectomy System - Aspiration Catheter - 00860009303409

The Aventus Aspiration Catheter is a multi-lumen catheter with a flexible shaft and a tapered radiopaque tip designed to remove thrombus and emboli from the peripheral and/or pulmonary vasculature using manual aspiration.
Inquis Medical, Inc.
IM-2001
In Commercial Distribution

  • 00860009303409 ()


  • Thrombectomy suction catheter
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