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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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Lumicell Direct Visualization System (DVS) - 00860003252567

Calibration Plate, Disposable
Lumicell, Inc.
810-00214
In Commercial Distribution

  • 00860008537829 ()
  • 10860003252564 ()
  • 00860003252567 ()


  • Intraoperative tumour margin fluorescence imaging system probe calibrator

Lumicell Direct Visualization System (DVS) - 00860003252550

Handheld Probe
Lumicell, Inc.
810-00211
In Commercial Distribution

  • 00860003252550 ()
  • 00860003252581 ()

  • Length: 1.28 Inch
810-00211

  • Intraoperative tumour margin fluorescence imaging system probe

Lumicell Direct Visualization System (DVS) - 00860003252543

Workstation Assembly
Lumicell, Inc.
810-00217
In Commercial Distribution

  • 00860003252543 ()
  • 00860008537805 ()


  • Intraoperative tumour margin fluorescence imaging system

Lumicell Direct Visualization System (DVS) - 00860003252536

Light source
Lumicell, Inc.
810-00212
In Commercial Distribution

  • 00860003252598 ()
  • 00860003252536 ()


  • Intraoperative tumour margin fluorescence imaging system

Lumicell Direct Visualization System (DVS) - 00860003252505

Sterile Cover
Lumicell, Inc.
810-00210
In Commercial Distribution

  • 00860003252512 ()
  • 00860003252505 ()
  • 00860008537812 ()


  • Intraoperative tumour margin fluorescence imaging system probe cover/spacer

Lumicell Direct Visualization System (DVS) - 00860008537898

Sterilization Tray
Lumicell, Inc.
900-00209
In Commercial Distribution

  • 00860008537898 ()


  • Device sterilization/disinfection container, reusable

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161012128

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi with Qid 230 cc
Establishment Labs S.A.
ERSD-230Q
In Commercial Distribution

  • 07445161012128 ()
ERSD-230Q

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161012111

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi with Qid 215 cc
Establishment Labs S.A.
ERSD-215Q
In Commercial Distribution

  • 07445161012111 ()
ERSD-215Q

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161012104

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi with Qid 205 cc
Establishment Labs S.A.
ERSD-205Q
In Commercial Distribution

  • 07445161012104 ()
ERSD-205Q

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161012098

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi with Qid 190 cc
Establishment Labs S.A.
ERSD-190Q
In Commercial Distribution

  • 07445161012098 ()
ERSD-190Q

  • Silicone gel-filled breast implant, smooth-surface
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