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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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NA - EPTWS0700270

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
Track-it software
In Commercial Distribution

  • EPTWS0700270 ()
S070027

  • Multi-modality therapeutic radiation phantom, anthropomorphic

DIAMOND - EPTWS0700200

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
DIAMOND software
In Commercial Distribution

  • EPTWS0700200 ()
S070020

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NA - EPTWS0700190

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
IsoCheck software
In Commercial Distribution

  • EPTWS0700190 ()
S070019

  • Multi-modality therapeutic radiation phantom, anthropomorphic

QUICKCHECK webline - EPTWS0700170

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
QUICKCHECK software
In Commercial Distribution

  • EPTWS0700170 ()
S070017

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NA - EPTWS0700160

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
DAVID software
In Commercial Distribution

  • EPTWS0700160 ()
S070016

  • Multi-modality therapeutic radiation phantom, anthropomorphic

MLCSoft - EPTWS0700140

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
MLCSoft software
In Commercial Distribution

  • EPTWS0700140 ()
S070014

  • Multi-modality therapeutic radiation phantom, anthropomorphic

MultiCheck - EPTWS0700110

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
MultiCheck Software
In Commercial Distribution

  • EPTWS0700110 ()
S070011

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NA - EPTWS0700100

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
epidSoft software
In Commercial Distribution

  • EPTWS0700100 ()
S070010

  • Multi-modality therapeutic radiation phantom, anthropomorphic

VeriSoft - EPTWS0700090

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
VeriSoft software
In Commercial Distribution

  • EPTWS0700090 ()
S070009

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NA - EPTWS0700080

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
MultiCal software
In Commercial Distribution

  • EPTWS0700080 ()
S070008

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NA - EPTWS0700070

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
WedgeAngle Software
In Commercial Distribution

  • EPTWS0700070 ()
S070007

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NOMEX - EPTWS0300080

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
NOMEX software
In Commercial Distribution

  • EPTWS0300080 ()
S030008

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NA - EPTWS0200120

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
DiaCanSet software
In Commercial Distribution

  • EPTWS0200120 ()
S020012

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NA - EPTWS0200110

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
DiaCom software
In Commercial Distribution

  • EPTWS0200110 ()
S020008

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NA - EPTWS0200080

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
DiaCom software
In Commercial Distribution

  • EPTWS0200080 ()
S020008

  • Multi-modality therapeutic radiation phantom, anthropomorphic

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

Rapid - B761R51020

Rapid System Update
Ischemaview, Inc.
5.102
In Commercial Distribution

  • B761R51020 ()


  • Radiological PACS software

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

UltraviewSL - 10841522108754

OPTION, BISX BASE MODULE, REFURB
SPACELABS HEALTHCARE (WASHINGTON), INC
91482
In Commercial Distribution

  • 10841522108754 ()
N/A

  • Patient monitoring system module, electroencephalographic

UltraviewSL - 10841522100253

MODULE BISX, 91482
SPACELABS HEALTHCARE (WASHINGTON), INC
Module: BISx
In Commercial Distribution

  • 10841522100253 ()
91482

  • Patient monitoring system module, electroencephalographic

N/A - 00613994467089

SOFTWARE 9733808 DICOM Q/R
MEDTRONIC NAVIGATION, INC.
9733808
In Commercial Distribution

  • 00613994467089 ()


  • Multi-purpose stereotactic surgery system

N/A - 00613994570369

SOFTWARE 9734150 UNIVERSAL ITHR S7
MEDTRONIC NAVIGATION, INC.
9734150
In Commercial Distribution

  • 00613994570369 ()


  • Orthopaedic stereotactic surgery system

NA - 00613994570352

SOFTWARE 9734149 UNIVERSAL ITKR S7
MEDTRONIC NAVIGATION, INC.
9734149
In Commercial Distribution

  • 00613994570352 ()


  • Orthopaedic stereotactic surgery system

N/A - 00613994556127

SOFTWARE 9734108 StealthViz INT WIN32
MEDTRONIC NAVIGATION, INC.
9734108
In Commercial Distribution

  • 00613994556127 ()


  • Neurological stereotactic surgery system

EX-M1 - 04547410448214

A hardware for installing software.
FUJIFILM CORPORATION
DR-ID1200 GPU EX-M1 MDR E
In Commercial Distribution

  • 04547410448214 ()


  • Diagnostic x-ray digital imaging conversion system

AVEA - 10190752159075

KIT, AVEA UPGRADE GDE & SOFTWARE
VYAIRE MEDICAL, INC.
12284-PMN
Not in Commercial Distribution

  • 10190752159075 ()
12284-PMN

  • Patient monitoring system module, pulse oximetry
  • Ventilator application software

NA - 00643169648975

SOFTWARE CD S0278-00 GRAV FIT
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169648975 ()


  • Audiometric/hearing device software

Cycler Control v2.2 - 00858637005871

Exact Sciences Software System 2.2
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005871 ()


  • Laboratory instrument/analyser application software IVD

STARlet Interface v2.2 - 00858637005864

Exact Sciences Software System 2.2
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005864 ()


  • Laboratory instrument/analyser application software IVD

Analysis Client v2.2 - 00858637005857

Exact Sciences Software System 2.2
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005857 ()


  • Laboratory instrument/analyser application software IVD

Analysis Server v2.2 - 00858637005840

Exact Sciences Software System 2.2
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005840 ()


  • Laboratory instrument/analyser application software IVD

N/A - 00643169272583

SOFTWARE KIT 9735235 MICROSCOPE ROBOTICS
MEDTRONIC NAVIGATION, INC.
9735235
In Commercial Distribution

  • 00643169272583 ()


  • Neurological stereotactic surgery system

VistaScan™ - 00850017464001

VistaScan™ Software 1.x.x
EMAGINE SOLUTIONS TECHNOLOGY LLC
1.x.x
In Commercial Distribution

  • 00850017464001 ()


  • Ultrasound imaging system application software

Synergy® Spine & Trauma - 00643169480957

SOFTWARE 9733686 S7 SYNERGY SPINE
MEDTRONIC NAVIGATION, INC.
9733686
In Commercial Distribution

  • 00643169480957 ()


  • Multi-purpose stereotactic surgery system

LiDCO - 05060110523016

Software Upgrade, LiDCOunity v1.01 (b1943)
LIDCO LIMITED
Li11238
In Commercial Distribution

  • 05060110523016 ()
Li11238

  • General-purpose multi-parameter bedside monitor

LiDCO - 05060110522934

Software Upgrade, LiDCOunity v2.03 (b318)
LIDCO LIMITED
Li11197
In Commercial Distribution

  • 05060110522934 ()
Li11197

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110522613

Software Upgrade, LiDCOrapid v2.06 (b1328)
LIDCO LIMITED
Li11151
In Commercial Distribution

  • 05060110522613 ()
Li11151

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110522156

Software Upgrade, LiDCOunity v1.01 (b1935)
LIDCO LIMITED
Li11150
In Commercial Distribution

  • 05060110522156 ()
Li11150

  • General-purpose multi-parameter bedside monitor

Synergy®Cranial - 00643169503311

SOFTWARE 9733763 SYNERGY CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733763
In Commercial Distribution

  • 00643169503311 ()


  • Multi-purpose stereotactic surgery system

N/A - 00643169494916

SOFTWARE 9735462XOM DICOM LICENSE ENT
MEDTRONIC NAVIGATION, INC.
9735462XOM
Not in Commercial Distribution

  • 00643169494916 ()


  • Multi-purpose stereotactic surgery system

N/A - 00643169492264

SOFTWARE KIT 9733652XOM Fusion ENT-EU-SW
MEDTRONIC NAVIGATION, INC.
9733652XOM
Not in Commercial Distribution

  • 00643169492264 ()


  • ENT stereotactic surgery system

N/A - 00643169492257

SOFTWARE KIT 9733652XOM Fusion ENT-EU-SE
MEDTRONIC NAVIGATION, INC.
9733652XOM
Not in Commercial Distribution

  • 00643169492257 ()


  • ENT stereotactic surgery system

N/A - 00643169492233

SOFTWARE KIT 9733652XOM Fusion ENT-SCAND
MEDTRONIC NAVIGATION, INC.
9733652XOM
Not in Commercial Distribution

  • 00643169492233 ()


  • ENT stereotactic surgery system

N/A - 00643169492226

SOFTWARE KIT 9733652XOM Fusion ENT-EU-NW
MEDTRONIC NAVIGATION, INC.
9733652XOM
Not in Commercial Distribution

  • 00643169492226 ()


  • ENT stereotactic surgery system

N/A - 00643169491960

SOFTWARE 9735462 DICOM LICENSE ENT
MEDTRONIC NAVIGATION, INC.
9735462
In Commercial Distribution

  • 00643169491960 ()


  • Multi-purpose stereotactic surgery system

N/A - 00643169491748

SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00643169491748 ()


  • ENT stereotactic surgery system

Leica Biosystems Ariol Review Software - 00849832003830

Leica Biosystems Ariol Review Software
Leica Biosystems Richmond, Inc.
23ASWREV001
In Commercial Distribution

  • 00849832003830 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

N/A - 00613994680891

SOFTWARE 9734400XOM STEALTHMERGE ENT PG
MEDTRONIC NAVIGATION, INC.
9734400XOM
In Commercial Distribution

  • 00613994680891 ()


  • Multi-purpose stereotactic surgery system
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