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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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MANUAL ENDOSCOPIC SPRAY APP. W/MIX TIP 5MM X 40CM,11:1 RATIO
Micromedics, Inc.
SA-3667
In Commercial Distribution

  • 00815634020184 ()
  • 10815634020181 ()
  • 20815634020188 ()


  • 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
No Description
Thought Technology Ltd.
SA4515
In Commercial Distribution

  • 07540191000630 ()


  • Psychophysiological biofeedback system
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
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

  • 07290017025100 ()
MLL-EG30001

  • Radiology information system application software
STYLE 410, FF, 160G
Allergan, Inc.
FF-410160
Not in Commercial Distribution

  • 10888628002616 ()

  • 160 cc
FF-410160

  • Silicone gel-filled breast implant
STYLE 410, FM, 180G
Allergan, Inc.
FM-410180
Not in Commercial Distribution

  • 10888628002807 ()

  • 180 cc
FM-410180

  • Silicone gel-filled breast implant
STYLE 410, FM, 155G
Allergan, Inc.
FM-410155
Not in Commercial Distribution

  • 10888628002791 ()

  • 155 cc
FM-410155

  • Silicone gel-filled breast implant
Natrelle Inspira X-Full 800cc SSZ US
Allergan, Inc.
SSZ-X800
In Commercial Distribution

  • 10888628045972 ()

  • 800 cc
SSZ-X800

  • Invasive breast implant sizer, fixed, single-use
Natrelle Inspira X-Full 750cc SSZ US
Allergan, Inc.
SSZ-X750
In Commercial Distribution

  • 10888628045965 ()

  • 750 cc
SSZ-X750

  • Invasive breast implant sizer, fixed, single-use
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