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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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Omnipod 5 Controller - 10385083000022

Omnipod 5 Controller (PDM) mg/dl - English with PodPals
Insulet Corporation
PDM-H001-G-XX
In Commercial Distribution

  • 10385083000022 ()
  • 30385083000019 ()
  • 30385083000095 ()
SKT-H001-G-X9

  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

Omnipod 5 Controller APP - 10385081120302

Actual downloadable APP, called Omnipod 5 Controller APP
Insulet Corporation
1.0
In Commercial Distribution

  • 10385081120302 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

ORTHO - 10758750012763

OAS Server for VERSEIA Integrated Processor (VIP)
ORTHO-CLINICAL DIAGNOSTICS, INC.
6842840
In Commercial Distribution

  • 10758750012763 ()
6842840

  • Laboratory instrument/analyser application software IVD

ORTHO - 10758750005505

OAS Server - 450 MHz, Refurbished
ORTHO-CLINICAL DIAGNOSTICS, INC.
936416F
In Commercial Distribution

  • 10758750005505 ()
936416F

  • Laboratory instrument/analyser application software IVD

ORTHO - 10758750005499

OAS Server for Summit Sample Handling System
ORTHO-CLINICAL DIAGNOSTICS, INC.
936416
In Commercial Distribution

  • 10758750005499 ()
936416

  • Laboratory instrument/analyser application software IVD

ORTHO - 10758750005482

OAS 400 MHz Workstation Refurbished for Summit Sample Handling System
ORTHO-CLINICAL DIAGNOSTICS, INC.
936415F
In Commercial Distribution

  • 10758750005482 ()
936415F

  • Laboratory instrument/analyser application software IVD

dIFine ANCA Classifier - 08059304340239

No Description
VISIA LAB SRL
dIFine ANCA Classifier
In Commercial Distribution

  • 08059304340239 ()


  • Laboratory instrument/analyser application software IVD

dIFine DNA Classifier - 08059304340222

No Description
VISIA LAB SRL
dIFine DNA Classifier
In Commercial Distribution

  • 08059304340222 ()


  • Laboratory instrument/analyser application software IVD

dIFine ANA HEp-2 Classifier - 08059304340215

No Description
VISIA LAB SRL
dIFine ANA HEp-2 Classifier
In Commercial Distribution

  • 08059304340215 ()


  • Laboratory instrument/analyser application software IVD

WaveLight - 00380659984372

Diagnostic device to perform non-contact measurements of the corneal tomography, anterior chamber parameter, pupil diameter, axial length, and optical aberrations of the patient’s eye.
Alcon Laboratories, Inc.
1023
In Commercial Distribution

  • 00380659984372 ()
8065998437

  • Eye anterior segment analyser
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