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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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Powerheart® G3 Elite AED, Semi-Automatic, Korean, with Adult Pads and Battery
Zoll Medical Corporation
9790E-1019
In Commercial Distribution

  • 00812394023127 ()
9790E-1019

  • Non-rechargeable public semi-automated external defibrillator
Beta-Rail 3.5F XL Delivery Catheter for use with the Novoste Beta-Cath System
BEST VASCULAR, INC.
BRX-0346
In Commercial Distribution

  • M097BRX03460 ()
BRX-0346

  • Coronary artery brachytherapy system applicator, manual-afterloading
G3Plus, AED, Semi Automatic, AHA 2010, with adult pads and TSO battery
Zoll Medical Corporation
9390E-1001-TSO
In Commercial Distribution

  • 00812394023349 ()
9390E-1001-TSO

  • Non-rechargeable public semi-automated external defibrillator
G3Plus, AED, Automatic ,AHA 2010, with adult pads and battery, stocking package
Zoll Medical Corporation
9390A-1001SP
In Commercial Distribution

  • 00812394023295 ()
9390A-1001SP

  • Non-rechargeable public automated external defibrillator
G3, AED, Semi-Automatic ,AHA 2010, TSO with adult pads and TSO battery
Zoll Medical Corporation
9300E-1001-TSO
In Commercial Distribution

  • 00812394023219 ()
9300E-1001-TSO

  • Non-rechargeable public semi-automated external defibrillator
OBALON® Balloon Evacuator - component for use with the OBALON® Balloon
ReShape Lifesciences Inc.
6300-0001
Not in Commercial Distribution

  • 00859810006173 ()


  • Appetite-suppression gastric balloon deployment device/set
Trabecular Micro-Bypass System
GLAUKOS CORPORATION
iS2
In Commercial Distribution

  • 00853704002487 ()
iS2

  • Glaucoma micro-stent
Dome Pack
MENTOR TEXAS L.P.
350-DOMPK
In Commercial Distribution

  • 00081317004059 ()
350-DOMPK

  • Saline-filled breast implant, unstructured, smooth-surface
CLAREON VIVITY TORIC AUTONOME
Alcon Laboratories, Inc.
CNAET6
In Commercial Distribution

  • 00380652484824 ()

  • Optic Diameter, 6.0mm
  • Overall Length, 13.0mm
CNAET6.110

  • Posterior-chamber intraocular lens, pseudophakic
CLAREON VIVITY TORIC AUTONOME
Alcon Laboratories, Inc.
CNAET6
In Commercial Distribution

  • 00380652484800 ()

  • Optic Diameter, 6.0mm
  • Overall Length, 13.0mm
CNAET6.100

  • Posterior-chamber intraocular lens, pseudophakic
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