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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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Duet™ - 07290107653053

No Description
BIO-VIEW LTD
Solo Software
In Commercial Distribution

  • 07290107653053 ()


  • Fluorescence light microscope

Affirm Prone Biopsy System - 15420045504721

No Description
Hologic, Inc.
System Software
In Commercial Distribution

  • 15420045504721 ()


  • Mammographic stereotactic biopsy system

I-View - 15420045512658

No Description
Hologic, Inc.
I-View Software
In Commercial Distribution

  • 15420045512658 ()
SW-03078

  • Stationary mammographic x-ray system, digital

3DQuorum - 15420045512313

3DQuorum® is an image processing software application for post-processing tomosynthesis data captured on a Hologic tomosynthesis imaging system, into a combined 3D image.
Hologic, Inc.
3DQUORUM SOFTWARE
In Commercial Distribution

  • 15420045512313 ()
SW-05673

  • Stationary mammographic x-ray system, digital

3Dimensions - 15420045507296

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Hologic, Inc.
3DIMENSIONS SOFTWARE
In Commercial Distribution

  • 15420045507296 ()
SW-04883

  • Stationary mammographic x-ray system, digital

Selenia Dimensions 3D System - 15420045500013

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Hologic, Inc.
3D software
In Commercial Distribution

  • 15420045500013 ()
SW-01648

  • Stationary mammographic x-ray system, digital

BIS Module - 00884838051515

IntelliVue Bispectral Index (BIS) Module M1034B for use with IntelliVue Patient Monitors MP40-MP90 and MX500-MX800. Bispectral Index (BIS) monitoring helps to monitor the level of consciousness of a patient under general anesthesia or sedation in the OR and ICU.
Philips Medizin Systeme Böblingen GmbH
IntelliVue BIS Module
In Commercial Distribution

  • 00884838051515 ()
866421

  • Patient monitoring system module, interfacing

BIS - 10884521808317

BIS (TM) Advance Monitor
Covidien LP
PMB4000ACBL
In Commercial Distribution

  • 10884521808317 ()


  • Analytical scalp lead

BIS - 10884521808300

BIS (TM) Advance Docking Station
Covidien LP
PMB4000DOC
In Commercial Distribution

  • 10884521808300 ()


  • Anaesthesia depth monitor

BIS - 10884521808270

BIS (TM) Advance Monitor
Covidien LP
PMB4000
In Commercial Distribution

  • 10884521808270 ()


  • Anaesthesia depth monitor
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