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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 Semi-Automatic AED Kit - 00812394023127

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

B-Rail 3.5F XL Delivery Catheter - M097BRX03460

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

Powerheart® AED G3 Plus Semi Automatic - 00812394023349

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

Powerheart® AED G3 Plus Automatic AED, stocking package - 00812394023295

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

Powerheart® AED G3 Semi Automatic AED - 00812394023219

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® - 00859810006173

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

iStent inject W Trabecular Micro-Bypass System with Infinite Injector Technology - 00853704002487

Trabecular Micro-Bypass System
GLAUKOS CORPORATION
iS2
In Commercial Distribution

  • 00853704002487 ()
iS2

  • Glaucoma micro-stent

MENTOR Injection Domes with Stainless Steel TRUE LOCK Connection Systems - 00081317004059

Dome Pack
MENTOR TEXAS L.P.
350-DOMPK
In Commercial Distribution

  • 00081317004059 ()
350-DOMPK

  • Saline-filled breast implant, unstructured, smooth-surface

Clareon Vivity Toric Extended Vision Hydrophobic IOLs with the AutonoMe - 00380652484824

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 Extended Vision Hydrophobic IOLs with the AutonoMe - 00380652484800

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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