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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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SoftBiochemistry - 00810055810826

No Description
SCC SOFT COMPUTER
4.1.11.17
In Commercial Distribution

  • 00810055810826 ()


  • Clinical laboratory information system application software

SoftTrack - 00810055810819

No Description
SCC SOFT COMPUTER
4.1.14.5
In Commercial Distribution

  • 00810055810819 ()


  • Clinical laboratory information system application software

SoftGenePortal - 00810055810802

No Description
SCC SOFT COMPUTER
4.1.14.5
In Commercial Distribution

  • 00810055810802 ()


  • Clinical laboratory information system application software

SoftIWS - 00810055810796

No Description
SCC SOFT COMPUTER
4.1.14.5
In Commercial Distribution

  • 00810055810796 ()


  • Clinical laboratory information system application software

SoftMolecular - 00810055810789

No Description
SCC SOFT COMPUTER
4.1.14.5
In Commercial Distribution

  • 00810055810789 ()


  • Clinical laboratory information system application software

SoftHLA - 00810055810772

No Description
SCC SOFT COMPUTER
4.1.14.5
In Commercial Distribution

  • 00810055810772 ()


  • Clinical laboratory information system application software

SoftFlowcytometry - 00810055810765

No Description
SCC SOFT COMPUTER
4.1.14.5
In Commercial Distribution

  • 00810055810765 ()


  • Clinical laboratory information system application software

SoftPathDx - 00810055810758

No Description
SCC SOFT COMPUTER
4.1.14.5
In Commercial Distribution

  • 00810055810758 ()


  • Clinical laboratory information system application software

SoftCytogenetics - 00810055810741

No Description
SCC SOFT COMPUTER
4.1.14.5
In Commercial Distribution

  • 00810055810741 ()


  • Clinical laboratory information system application software

SoftBiochemistry - 00810055810734

No Description
SCC SOFT COMPUTER
4.1.14.5
In Commercial Distribution

  • 00810055810734 ()


  • Clinical laboratory information system application software

SoftBank - 00810055810727

No Description
SCC SOFT COMPUTER
25.5.6.2
In Commercial Distribution

  • 00810055810727 ()


  • Blood bank information system application software

SoftTrack - 00810055810598

No Description
SCC SOFT COMPUTER
4.1.14.4
In Commercial Distribution

  • 00810055810598 ()


  • Clinical laboratory information system application software

SoftGenePortal - 00810055810581

No Description
SCC SOFT COMPUTER
4.1.14.4
In Commercial Distribution

  • 00810055810581 ()


  • Clinical laboratory information system application software

SoftIWS - 00810055810574

No Description
SCC SOFT COMPUTER
4.1.14.4
In Commercial Distribution

  • 00810055810574 ()


  • Clinical laboratory information system application software

SoftMolecular - 00810055810567

No Description
SCC SOFT COMPUTER
4.1.14.4
In Commercial Distribution

  • 00810055810567 ()


  • Clinical laboratory information system application software

SoftHLA - 00810055810550

No Description
SCC SOFT COMPUTER
4.1.14.4
In Commercial Distribution

  • 00810055810550 ()


  • Clinical laboratory information system application software

SoftFlowCytometry - 00810055810543

No Description
SCC SOFT COMPUTER
4.1.14.4
In Commercial Distribution

  • 00810055810543 ()


  • Clinical laboratory information system application software

SoftPathDx - 00810055810536

No Description
SCC SOFT COMPUTER
4.1.14.4
In Commercial Distribution

  • 00810055810536 ()


  • Clinical laboratory information system application software

SoftCytogenetics - 00810055810529

No Description
SCC SOFT COMPUTER
4.1.14.4
In Commercial Distribution

  • 00810055810529 ()


  • Clinical laboratory information system application software

SoftBiochemistry - 00810055810512

No Description
SCC SOFT COMPUTER
4.1.14.4
In Commercial Distribution

  • 00810055810512 ()


  • Clinical laboratory information system application software

SoftTrack - 00810055810376

No Description
SCC SOFT COMPUTER
3.4.3.26
In Commercial Distribution

  • 00810055810376 ()


  • Clinical laboratory information system application software

SoftPathDx - 00810055810369

No Description
SCC SOFT COMPUTER
3.4.3.26
In Commercial Distribution

  • 00810055810369 ()


  • Clinical laboratory information system application software

SoftTrack - 00810055810079

No Description
SCC SOFT COMPUTER
4.1.11.16
In Commercial Distribution

  • 00810055810079 ()


  • Clinical laboratory information system application software

SoftMolecular - 00810055810062

No Description
SCC SOFT COMPUTER
4.1.11.16
In Commercial Distribution

  • 00810055810062 ()


  • Clinical laboratory information system application software

SoftFlowCytometry - 00810055810055

No Description
SCC SOFT COMPUTER
4.1.11.16
In Commercial Distribution

  • 00810055810055 ()


  • Clinical laboratory information system application software

SoftPathDx - 00810055810048

No Description
SCC SOFT COMPUTER
4.1.11.16
In Commercial Distribution

  • 00810055810048 ()


  • Clinical laboratory information system application software

SoftCytogenetics - 00810055810031

No Description
SCC SOFT COMPUTER
4.1.11.16
In Commercial Distribution

  • 00810055810031 ()


  • Clinical laboratory information system application software

SoftBiochemistry - 00810055810024

No Description
SCC SOFT COMPUTER
4.1.11.16
In Commercial Distribution

  • 00810055810024 ()


  • Clinical laboratory information system application software

SoftBiobank - 00810142372886

No Description
SCC SOFT COMPUTER
1.0.1.9
In Commercial Distribution

  • 00810142372886 ()


  • Clinical laboratory information system application software

SoftGenePortal - 00810142372961

No Description
SCC SOFT COMPUTER
4.2.0.11
In Commercial Distribution

  • 00810142372961 ()


  • Clinical laboratory information system application software

FilmArray® 2.0 Instrument NGDS Configuration - 00851458005143

NGDS FilmArray Configuration kit (no computer included).
BIOFIRE DEFENSE, LLC
NGDS-ASY-0004
In Commercial Distribution

  • 00851458005143 ()
NGDS-ASY-0004

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

CompuFlo Epidural Computer Controlled Anesthesia System - 00618874116040

CompuFlo Epidural Computer Controlled Anesthesia System 220V
Milestone Scientific Inc.
EPI-6000-220
In Commercial Distribution

  • 00618874116040 ()


  • Electronic epidural space locator control unit

CompuFlo Epidural Computer Controlled Anesthesia System - 00618874116033

CompuFlo Epidural Computer Controlled Anesthesia System 110V
Milestone Scientific Inc.
EPI-6000-110
In Commercial Distribution

  • 00618874116033 ()


  • Electronic epidural space locator control unit

BD FocalPoint™ GS Review Station - 00382904901899

BD FocalPoint™ GS Review Station Computer
BECTON, DICKINSON AND COMPANY
490189
In Commercial Distribution

  • 00382904901899 ()

  • Height: 33.2 Centimeter
  • Width: 55 Centimeter
  • Length: 59.2 Centimeter
490189

  • Cell morphology analyser IVD, manual

MammoScreen - B885MAML2US0

Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAL2US
In Commercial Distribution

  • B885MAML2US0 ()


  • X-ray image interpretive software

MammoScreen - B885MAML0

Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAML
In Commercial Distribution

  • B885MAML0 ()
MAML

  • X-ray image interpretive software

Vita LE CR System - 60889971067708

NB VITA LE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita LE CR System
In Commercial Distribution

  • 60889971067708 ()
1067701

  • Computed radiography digital imaging scanner

Vita XE CR System - 60889971067685

NB VITA XE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita XE CR System
In Commercial Distribution

  • 60889971067685 ()
1067685

  • Computed radiography digital imaging scanner

Esteem® Intraoperative System Analyzer - 00812282020160

Intraoperative System Analyzer (ISA), Software and Computer
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020160 ()
903001-003

  • Fully-implantable middle ear implant system

FUJIFILM - 04547410389005

This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CP-1TB
In Commercial Distribution

  • 04547410389005 ()


  • Computer/medical device keyboard
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