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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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neoprobe - 00841911100218

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DEVICOR MEDICAL PRODUCTS, INC.
NEOCART1
In Commercial Distribution

  • 00841911100218 ()
NEOCART1

  • Hand-held-detector nuclear medicine system

cobas c 513 clinical chemistry analyzer - 04015630946327

No Description
Roche Diagnostics GmbH
07649142001
Not in Commercial Distribution

  • 04015630946327 ()
07649142001

  • Multi-modality clinical specimen analysis system IVD

cobas 8000 c 701 Module - 04015630928255

No Description
Roche Diagnostics GmbH
5641489001
Not in Commercial Distribution

  • 04015630928255 ()
5641489001

  • Multi-modality clinical specimen analysis system IVD

cobas 6000 core unit - 04015630924691

No Description
Roche Diagnostics GmbH
4745868001
In Commercial Distribution

  • 04015630924691 ()
4745868001

  • Multi-modality clinical specimen analysis system IVD

Quantum ® - 05060434420039

Quantum Data Management Unit
SPECTRUM MEDICAL LIMITED
QDMU
In Commercial Distribution

  • 05060434420039 ()
3008-001-010

  • Patient health record information system

System M ® - 05060434420015

Data Management Monitor
SPECTRUM MEDICAL LIMITED
VIPER DM
In Commercial Distribution

  • 05060434420015 ()
3005-001-200

  • Patient health record information system

Evidence MultiSTAT - 05055273214970

The Evidence MultiSTAT is a benchtop, fully automated, immunoassay analyser that has been designed and developed to be operated in a wide range of laboratory settings within different industries. These include clinical, hospital, academic, research and development, veterinary and food laboratories.
RANDOX LABORATORIES LIMITED
EV4115
In Commercial Distribution

  • 05055273214970 ()
EV4115

  • Multiplex analyser IVD, laboratory

RadimetricsTM Enterprise Platform - 00616258008851

"RADIMETRICS Enterprise Platform (60777193)"
BAYER MEDICAL CARE INC.
EXP-XX
In Commercial Distribution

  • 00616258008851 ()
EXP-XX

  • Patient health record information system

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

UDM (Urinalysis Data Manager) - 04987562488506

No Description
SYSMEX CORPORATION
1.X
In Commercial Distribution

  • 04987562488506 ()
AB364503

  • Clinical laboratory information system
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