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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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SW-Key: NMG_SCENIUM_ADV - 04056869002095

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08716651
In Commercial Distribution

  • 04056869002095 ()


  • SPECT system application software
  • PET system application software

syngo.MM Oncology - 04068151009453

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11589577
In Commercial Distribution

  • 04068151009453 ()


  • PET system application software
  • SPECT system application software

syngo.MI General - 04068151009460

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11589500
In Commercial Distribution

  • 04068151009460 ()


  • PET system application software
  • SPECT system application software

OR Barcode Scanner - 00850015699016

After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other implanted TKA components.
Canary Medical USA LLC
43-5570-006-14
In Commercial Distribution

  • 00850015699016 ()


  • Patient health record information system

Quantum ® - 05060434420039

Quantum Data Management Unit
SPECTRUM MEDICAL LIMITED
QDMU
Not in Commercial Distribution

  • 05060434420039 ()
3008-001-010

  • Patient health record information system

System M ® - 05060434420015

Data Management Monitor
SPECTRUM MEDICAL LIMITED
VIPER DM
Not in Commercial Distribution

  • 05060434420015 ()
3005-001-200

  • Patient health record information system

eNcounter - 00850033167115

A complete telehealth platform that offers secure telemedicine software solutions with diagnostic and clinical workflow capabilities combined with interoperable services that work with an existing platform including scheduling, video consultations, data integration, and integration management services.
Globalmed Holdings, LLC
eNcounter
In Commercial Distribution

  • 00850033167115 ()


  • Patient health record information system

UDM (Urinalysis Data Manager) - 04987562488506

No Description
SYSMEX CORPORATION
1.X
In Commercial Distribution

  • 04987562488506 ()
AB364503

  • Clinical laboratory information system

Clinic Laptop - 00860003118382

No Description
Canary Medical USA LLC
43-5570-003-15
In Commercial Distribution

  • 00860003118382 ()


  • Patient health record information system

OR Laptop - 00860003118337

Dedicated Laptop PC, part of the OR Base Station System
Canary Medical USA LLC
43-5570-003-14
In Commercial Distribution

  • 00860003118337 ()


  • Patient health record information system
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