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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Robot Arm Interface instrument Rosa 3.0 instrument ROSA One spine app 3.1
MEDTECH
ROSA3-048A
Not in Commercial Distribution

  • 03760244030436 ()
ROSAS00126

  • Neurological stereotactic surgery system
  • Multi-purpose stereotactic surgery system
Ear thermometer with bluetooth which transmits data to app on mobile phone
Masena Invest B.V.
ET-624BT
In Commercial Distribution

  • 08719481720193 ()


  • Intermittent electronic patient thermometer
Pressure PreventionGroup 1 Surfaces Product Description: APP Pad Only, 1/ea, RTL
Drive Devilbiss Healthcare
14003
In Commercial Distribution

  • 50822383103742 ()
  • 00822383103747 ()


  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure bed mattress overlay system
RIGID ENDOSCOPIC AEROSOL APP. 5MM DIA X 40CM (16 IN) 1:1
Micromedics, Inc.
800-0217
In Commercial Distribution

  • 00815634020283 ()
  • 10815634020280 ()
  • 20815634020287 ()


  • Open-surgery adhesive/sealant applicator, dual-channel
The Astroid Planning App is a cloud based software used for treatment planning of proton radiation therapy treatments.
DECIMAL, INC.
3.x
In Commercial Distribution

  • 00851147007120 ()


  • Radiation therapy software
A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025124 ()
ML-EG30001

  • Radiology information system application software
No Description
MONOBIND, INC.
2275-300
In Commercial Distribution

  • 00816870023212 ()

  • Width: 7.75 Inch
2275-300B

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
No Description
MONOBIND, INC.
2275-300
In Commercial Distribution

  • 00816870023205 ()

  • Width: 7.75 Inch
2275-300A

  • Thyroglobulin IVD, kit, chemiluminescent immunoassay
No Description
MONOBIND, INC.
2225-300
In Commercial Distribution

  • 00816870021775 ()

  • Width: 7.75 Inch
2225-300B

  • Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
2225-300
In Commercial Distribution

  • 00816870021768 ()

  • Width: 7.75 Inch
2225-300A

  • Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
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