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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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SOFTWARE, CODE-STAT CASEVIEW SOFTWARE INSTALL
PHYSIO-CONTROL, INC.
21340
In Commercial Distribution

  • 00883873837788 ()
21340-000850

  • Medical equipment clinical data interfacing software
BRACKET 9735354 ZEISS PENTERO TOOLS DB
MEDTRONIC NAVIGATION, INC.
9735354
In Commercial Distribution

  • 00643169363878 ()


  • Multi-purpose stereotactic surgery system
BRACKET 9735352 NC4 LED TOOLS DB
MEDTRONIC NAVIGATION, INC.
9735352
In Commercial Distribution

  • 00643169363854 ()


  • Multi-purpose stereotactic surgery system
TRACKER 9735357 ACTV WIRELESS TOOLS DB
MEDTRONIC NAVIGATION, INC.
9735357
In Commercial Distribution

  • 00643169363830 ()


  • Multi-purpose stereotactic surgery system
BRACKET 9735355 ZEISS VARIO TOOLS DB
MEDTRONIC NAVIGATION, INC.
9735355
In Commercial Distribution

  • 00643169363816 ()


  • Multi-purpose stereotactic surgery system
BRACKET 9735356 LEICA MSCOPE TOOLS DB
MEDTRONIC NAVIGATION, INC.
9735356
In Commercial Distribution

  • 00643169363823 ()


  • Multi-purpose stereotactic surgery system
TOOLS AND FILLER EL153B LARGE KIT
MEDTRONIC SOFAMOR DANEK, INC.
EL153B
In Commercial Distribution

  • 00643169110212 ()

  • Extremities, Large Kit Assy, US, 15/3


  • Balloon kyphoplasty kit
TOOLS AND FILLER ES103B SMALL KIT
MEDTRONIC SOFAMOR DANEK, INC.
ES103B
In Commercial Distribution

  • 00643169157255 ()

  • Extremities, Small Kit Assy, US, 10/3


  • Balloon kyphoplasty kit
TOOLS AND FILLER EL153B LARGE KIT
MEDTRONIC SOFAMOR DANEK, INC.
EL153B
In Commercial Distribution

  • 00643169157248 ()

  • Extremities, Large Kit Assy, US, 15/3


  • Balloon kyphoplasty kit
REMOVAL SCREW FOR ABUTMENT - SEATING TOOLS
ACE SURGICAL SUPPLY CO., INC.
20957401
In Commercial Distribution

  • 00614950030101 ()
20957401

  • Dental prosthesis/implant abutment screw analog, single-use
BONE ACCESS TOOLS VPT13B 13GA BEVEL
MEDTRONIC SOFAMOR DANEK, INC.
VPT13B
Not in Commercial Distribution

  • 00643169637474 ()


  • Bone access channel kit
ASCB Installation Tools and Hardware Kit
ATRICURE, INC.
ASCB
In Commercial Distribution

  • 00818354016444 ()
A000810

  • Instrument trolley
MGUIDE tools kit for int. hex.
MIS Implants Technologies Ltd.
MG-KT01
In Commercial Distribution

  • 07290109013596 ()
MG-KT01

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
BONE ACCESS TOOLS VPT13B 13GA BEVEL
MEDTRONIC SOFAMOR DANEK, INC.
VPT13B
In Commercial Distribution

  • 00763000311858 ()


  • Bone access channel kit
BONE ACCESS TOOLS VPT13B 13GA BEVEL
MEDTRONIC SOFAMOR DANEK, INC.
VPT13B
In Commercial Distribution

  • 00763000026813 ()


  • Bone access channel kit
iSy® Re-Set Removal tools set
ALTATEC GmbH
P5900.1000
In Commercial Distribution

  • E219P590010001 ()
P5900.1000

  • Dental implant extractor
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11149925
Not in Commercial Distribution

  • 04056869006833 ()


  • Radiological PACS software
Actical Software Global
Respironics, Inc.
3.11
In Commercial Distribution

  • 00606959021013 ()
1081738

  • Kinesiology ambulatory recorder
No Description
OTODYNAMICS LIMITED
ILOv6
In Commercial Distribution

  • 05060396170713 ()


  • Otoacoustic emission system, line-powered
No Description
OTODYNAMICS LIMITED
EZ-Screen
In Commercial Distribution

  • 05060396170706 ()


  • Otoacoustic emission system, line-powered
The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together. The zensor+ software allows review of all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician. The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
INTELESENS LIMITED
PN0811
In Commercial Distribution

  • 05060484630051 ()


  • Electrocardiography telemetric monitoring system
The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together. The zensoronline software has the option to receive wirelessly transmitted pre-defined event alerts from the Intelesens' monitoring device for review by healthcare practitioners and/or review all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician. The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
INTELESENS LIMITED
PN0810
In Commercial Distribution

  • 05060484630044 ()


  • Electrocardiography telemetric monitoring system
Aurix software for use with the Aurix system (DI: 00627908080011) The UDI for software is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
Vivosonic Inc
SWA002
Not in Commercial Distribution

  • 00627908090027 ()


  • Evoked-potential audiometer
Integrity software for use with the first generation Integrity V500 system (DI: 00627908010018) and the second generation of the Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
Vivosonic Inc
SWA001
In Commercial Distribution

  • 00627908090010 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a preloaded workstation that is used to analyze sequencer data to generate applicable reports for the oncoReveal CDx
Pillar Biosciences, Inc.
SFW-2012 2.0
In Commercial Distribution

  • 00860001218275 ()
SFW-2012

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
No Description
Norland at Swissray
4
In Commercial Distribution

  • 00866955000478 ()


  • Basic diagnostic x-ray system operation software
No Description
WAHTS HEARING LLC
0.X.X
In Commercial Distribution

  • 00860005068319 ()


  • Tone audiometer
Breathing therapy Biofeedback System
ACCELERATED CARE PLUS CORP
FlowSoftware
In Commercial Distribution

  • 00858703006313 ()


  • Bioelectrical signal analysis software
Cervello Software for use with Blackrock Neuromed systems, version 1.04 and all sub releases.
BLACKROCK NEUROMED, LLC
RS-0003
In Commercial Distribution

  • 00850154007086 ()
RS-0003

  • Electroencephalography telemetric monitoring system
  • Bioelectrical signal analysis software
SeeMore Software 4.4.x
INTERSON CORP
4.4.x
In Commercial Distribution

  • 00850921007172 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
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