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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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GI Genius - 10884521807259

Intelligent Endoscopy Module
Covidien LP
CB1708-EU
In Commercial Distribution

  • 10884521807259 ()

  • Voltage, 100- 240, VAC;+/-10%,50/60,Hertz;Power,240,W;


  • Endoscopic video image interpretive unit

OrthoNext™ Platform System Software - 18053340345682

PREOPERATIVE JPS MODULE FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.1
In Commercial Distribution

  • 18053340345682 ()
JPSMODULESW

  • Radiological PACS software

OrthoNext™ Platform System Software - 18052469470008

PREOPERATIVE FITBONE MODULE FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.0
In Commercial Distribution

  • 18052469470008 ()
FITBONEMODULESW

  • Radiological PACS software

OrthoNext™ Platform System Software - 18059015375848

POSTOPERATIVE TLHEXMODULE VERSION 1.1 FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.1
In Commercial Distribution

  • 18059015375848 ()
TLHEXMODULESW1.1

  • Radiological PACS software

SureTune™ 4 - 00763000990442

SW B36104S SURETUNE4 DBS SERVER MDR
MEDTRONIC, INC.
B36104S
In Commercial Distribution

  • 00763000990442 ()


  • Implantable electrical stimulation device management software

SureTune™ 4 - 00763000990435

SW B36104C SURETUNE4 DBS CLIENT MDR
MEDTRONIC, INC.
B36104C
In Commercial Distribution

  • 00763000990435 ()


  • Implantable electrical stimulation device management software

SureTune™ 4 - 00763000990428

SW B36104A SURETUNE4 DBS STANDALONE MDR
MEDTRONIC, INC.
B36104A
In Commercial Distribution

  • 00763000990428 ()


  • Implantable electrical stimulation device management software

Kinesis Balance - 05391542950027

Kinesis Balance is a smartphone application for assessment of balance and falls risk in older adults. The product is software based and uses simple clinical questionnaires and the sensors embedded in a smartphone to measure balance and assess risk of falls. The application is intended to be used by older adults and their carers in the home.
KINESIS
2.0.1
In Commercial Distribution

  • 05391542950027 ()


  • Posturography system application software

Assess Balance - 00860010129111

No Description
Balance Tracking Systems Incorporated
Version 7
In Commercial Distribution

  • 00860010129111 ()


  • Posturography system application software

FTM-EVAL-AA - 03760349820062

FeetMe Evaluation mobileAndroid application version 3.Y.Z.
FEETME
3
In Commercial Distribution

  • 03760349820062 ()


  • Posturography system application software
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