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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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HEAD RING SCREWS SHORT - 07290015461375

Short single use short screws connecting stereotactic frame with patient skull during neuro MRI guided FUS treatment.
INSIGHTEC LTD
MPR000445-AA HEAD RING SCREWS SHORT
In Commercial Distribution

  • 07290015461375 ()
MPR000445-AA

  • Therapeutic oncological/gynaecological ultrasound system

ThinPrep - 15420045514140

Accessory kit with components for installation of the Genesis™ processor for customers utilizing the aliquot functionality.
Hologic, Inc.
ALIQUOT STARTER KIT, THINPREP GENESIS
In Commercial Distribution

  • 15420045514140 ()
PRD-05064

  • Microscope slide maker IVD

Probe unit - 07350094440088

Used with the Nevisense to perform lesion examinations on patients, using disposable electrodes attached to the probe.
Scibase AB
512-0003
In Commercial Distribution

  • 07350094440088 ()
512-0003

  • Neoplasm electrical impedance spectrometer

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161012432

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full with Qid 625 cc
Establishment Labs S.A.
ERSF-625Q
In Commercial Distribution

  • 07445161012432 ()
ERSF-625Q

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161012425

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full with Qid 550 cc
Establishment Labs S.A.
ERSF-550Q
In Commercial Distribution

  • 07445161012425 ()
ERSF-550Q

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161012418

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full with Qid 500 cc
Establishment Labs S.A.
ERSF-500Q
In Commercial Distribution

  • 07445161012418 ()
ERSF-500Q

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161012401

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full with Qid 450 cc
Establishment Labs S.A.
ERSF-450Q
In Commercial Distribution

  • 07445161012401 ()
ERSF-450Q

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161012395

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full with Qid 425 cc
Establishment Labs S.A.
ERSF-425Q
In Commercial Distribution

  • 07445161012395 ()
ERSF-425Q

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161012388

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full with Qid 400 cc
Establishment Labs S.A.
ERSF-400Q
In Commercial Distribution

  • 07445161012388 ()
ERSF-400Q

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161012371

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full with Qid 375 cc
Establishment Labs S.A.
ERSF-375Q
In Commercial Distribution

  • 07445161012371 ()
ERSF-375Q

  • Silicone gel-filled breast implant, smooth-surface
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