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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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Puritan Bennett - 10884521640870

800 Series Options Kit, German, 840 Neonatal Ventilator
Covidien LP
10051458
Not in Commercial Distribution

  • 10884521640870 ()


  • Ventilator application software

Puritan Bennett - 10884521640863

800 Series Options Kit, JAPANESE, Leak Compensation
Covidien LP
10035878
Not in Commercial Distribution

  • 10884521640863 ()


  • Ventilator application software

Puritan Bennett - 10884521609181

NOEMODE 2.0 SOFTWARE, FINISHED GOOD, FACTORY INSTALL
Covidien LP
10122274
Not in Commercial Distribution

  • 10884521609181 ()


  • Ventilator application software

Puritan Bennett - 10884521808546

High Flow Oxygen Therapy Option Software Upgrade;For 980 Series Ventilator
Covidien LP
980HFO2T
In Commercial Distribution

  • 10884521808546 ()


  • Ventilator application software

Puritan Bennett - 10884521808003

NIV plus Software Upgrade Option;For 980 Series Ventilator
Covidien LP
980NIVPLUS
In Commercial Distribution

  • 10884521808003 ()


  • Ventilator application software

Puritan Bennett - 10884521803305

980 Neonatal Expiratory Filtration System, Disposable
Covidien LP
980NEOFLT
In Commercial Distribution

  • 20884521803302 ()
  • 10884521803305 ()


  • Ventilator application software

Sonata® SMART Tablet - 10817929020197

Ultrasound -guided intrauterine electrosurgical system ultrasound control unit
Gynesonics, Inc.
USCON-2200
In Commercial Distribution

  • 10817929020197 ()
USCON-2200

  • Ultrasound-guided intrauterine radio-frequency ablation system ultrasound control unit

K-BALL - 03701313007942

K-BALL
S.M.A.I.O
01BK0001
In Commercial Distribution

  • 03701313007942 ()
01BK0001

  • CT phantom, test object

ResScan - 08401934313396

ResScan V7.0.2
RESMED CORP.
31339
In Commercial Distribution

  • 08401934313396 ()


  • Ventilator application software

ResScan - 08401934313389

ResScan v7.0.1
RESMED CORP.
31338
In Commercial Distribution

  • 08401934313389 ()


  • Ventilator application software

Model 4 CT Calibration Phantom - B052PHCTM40

Calibration phantom intended for use as an accessory to the QCT Pro Bone Mineral Densitometry Software.
MINDWAYS SOFTWARE, INC.
4
In Commercial Distribution

  • B052PHCTM40 ()


  • Bone densitometry x-ray phantom, test object

Home Monitoring Service Center - 07640130457300

No Description
BIOTRONIK SE & Co. KG
3.50
In Commercial Distribution

  • 07640130457300 ()
459761

  • Implantable cardiac device management application software

Catphan® - 00812266031403

High Resolution Module
Providus Holdings, Inc.
CTP764
In Commercial Distribution

  • 00812266031403 ()
CTP764

  • CT phantom, test object

Liver Phantom - 00812266030581

Liver Phantom, Simplified Torso Section with Image Quality Test Inserts
Providus Holdings, Inc.
CCT288
In Commercial Distribution

  • 00812266030581 ()
CCT288

  • CT phantom, test object

Low Contrast MITA Head Phantom - 00812266030574

Low Contrast MITA Head Phantom, MITA CT IQ Task Group Low Contrast Head Phantom
Providus Holdings, Inc.
CCT191
In Commercial Distribution

  • 00812266030574 ()
CCT191

  • CT phantom, test object

Low Contrast MITA Body Phantom - 00812266030567

Low Contrast MITA Body Phantom, MITA CT IQ Task Group Low Contrast Body Phantom
Providus Holdings, Inc.
CCT189
In Commercial Distribution

  • 00812266030567 ()
CCT189

  • CT phantom, test object

ATCM Phantom - 00812266030550

ATCM Phantom, Automatic Tube Current Modulation Phantom
Providus Holdings, Inc.
CCT228
In Commercial Distribution

  • 00812266030550 ()
CCT228

  • CT phantom, test object

Corgi® - 00812266030529

The Corgi® Phantom is a modular phantom designed for evaluation of cone beam imaging systems.
Providus Holdings, Inc.
CGI014
In Commercial Distribution

  • 00812266030529 ()
CGI014

  • CT phantom, test object

Catphan® - 00812266030512

16cm OD housing and mount
Providus Holdings, Inc.
CTP541
In Commercial Distribution

  • 00812266030512 ()
CTP541

  • CT phantom, test object

Catphan® - 00812266030505

Catphan® case
Providus Holdings, Inc.
CTP451
In Commercial Distribution

  • 00812266030505 ()
CTP451

  • CT phantom, test object

Catphan® - 00812266030499

Catphan® 600 mount assembly
Providus Holdings, Inc.
CTP627
In Commercial Distribution

  • 00812266030499 ()
CTP627

  • CT phantom, test object

Catphan® - 00812266030482

Catphan® 600 housing
Providus Holdings, Inc.
CTP623
In Commercial Distribution

  • 00812266030482 ()
CTP623

  • CT phantom, test object

Catphan® - 00812266030475

30 line pair high resolution module
Providus Holdings, Inc.
CTP714
In Commercial Distribution

  • 00812266030475 ()
CTP714

  • CT phantom, test object

Catphan® - 00812266030468

Geometry sensitometry and point source module
Providus Holdings, Inc.
CTP682
In Commercial Distribution

  • 00812266030468 ()
CTP682

  • CT phantom, test object

Catphan® - 00812266030451

40mm bead geometry module
Providus Holdings, Inc.
CTP591
In Commercial Distribution

  • 00812266030451 ()
CTP591

  • CT phantom, test object

Catphan® - 00812266030444

Subslice and supra-slice low contrast module
Providus Holdings, Inc.
CTP515
In Commercial Distribution

  • 00812266030444 ()
CTP515

  • CT phantom, test object

Catphan® - 00812266030437

Solid image uniformity module
Providus Holdings, Inc.
CTP486
In Commercial Distribution

  • 00812266030437 ()
CTP486

  • CT phantom, test object

Catphan® - 00812266030420

21 line pair high resolution and point source module
Providus Holdings, Inc.
CTP528
In Commercial Distribution

  • 00812266030420 ()
CTP528

  • CT phantom, test object

Catphan® - 00812266030413

Slice width, sensitometry and pixel size module
Providus Holdings, Inc.
CTP404
In Commercial Distribution

  • 00812266030413 ()
CTP404

  • CT phantom, test object

Catphan® - 00812266030406

Catphan® 608, Complete Catphan® including housing and case
Providus Holdings, Inc.
CTP608
In Commercial Distribution

  • 00812266030406 ()
CTP608

  • CT phantom, test object
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