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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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ThinPrep Imaging System - 15420045508156

Server for use with the ThinPrep® Imaging System to enable review.
Hologic, Inc.
ThinPrep Imaging System Server
In Commercial Distribution

  • 15420045508156 ()
CMP-01535

  • Network server

ThinPrep Imaging System - 15420045501027

Server for use with the ThinPrep® Imaging System to enable review.
Hologic, Inc.
ThinPrep Imaging System Server
In Commercial Distribution

  • 15420045501027 ()
CMP-01050

  • Network server

ThinPrep Imaging System - 15420045501010

Server for use with the ThinPrep® Imaging System to enable review.
Hologic, Inc.
ThinPrep Imaging System Server
In Commercial Distribution

  • 15420045501010 ()
CMP-00816

  • Network server

ThinPrep Imaging System - 15420045501003

Server for use with the ThinPrep® Imaging System to enable review.
Hologic, Inc.
ThinPrep Imaging System Server
In Commercial Distribution

  • 15420045501003 ()
71702-001

  • Network server

ThinPrep 5000 Processor - 15420045513945

Accessory kit with components for installation of the ThinPrep® 5000 processor.
Hologic, Inc.
TP-5000 Accessory Kit
In Commercial Distribution

  • 15420045513945 ()
71914-001

  • Microscope slide maker IVD

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

Clareon Vivity Toric Extended Vision Hydrophobic IOLs with the AutonoMe - 00380658407186

CLAREON VIVITY TORIC AUTONOME
Alcon Laboratories, Inc.
CNAET6
In Commercial Distribution

  • 00380658407186 ()

  • Optic Diameter, 6.0mm
  • Overall Length, 13.0mm
CNAET6.095

  • Posterior-chamber intraocular lens, pseudophakic

Clareon Vivity Toric Extended Vision Hydrophobic IOLs with the AutonoMe - 00380658407179

CLAREON VIVITY TORIC AUTONOME
Alcon Laboratories, Inc.
CNAET6
In Commercial Distribution

  • 00380658407179 ()

  • Optic Diameter, 6.0mm
  • Overall Length, 13.0mm
CNAET6.090

  • Posterior-chamber intraocular lens, pseudophakic

Clareon Vivity Toric Extended Vision Hydrophobic IOLs with the AutonoMe - 00380658407162

CLAREON VIVITY TORIC AUTONOME
Alcon Laboratories, Inc.
CNAET6
In Commercial Distribution

  • 00380658407162 ()

  • Optic Diameter, 6.0mm
  • Overall Length, 13.0mm
CNAET6.085

  • Posterior-chamber intraocular lens, pseudophakic
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