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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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ThinPrep Pap Test - 25420045501109

Glass slides for use with ThinPrep® processors for gynecological specimens.
Hologic, Inc.
ThinPrep® Pap Test Microscope Slides, 100pk
In Commercial Distribution

  • 25420045501109 ()
  • 15420045501102 ()
  • 35420045501106 ()
70373-001

  • Cervical cytology microscopy slide IVD

Pelvic RF Coil - 07290015461115

PHASE ARRAY ASSY Pelvic RF Coil for MRI imaging during Body FUS treatments. Contains Upper and Lower part: ASM000426-AA - UPPER PELVIC COIL PHASE ARRAY ASSY ASM000506-AA - LOWER PELVIC COIL PHASE ARRAY ASSY
INSIGHTEC LTD
Pelvic RF Coil for Body
In Commercial Distribution

  • 07290015461115 ()
ASM000956

  • Therapeutic oncological/gynaecological ultrasound system

Patient accessory kit - 07290015461047

UF/Bone1 clinical applications single use treatment kit
INSIGHTEC LTD
Patient accessory kit for Body
In Commercial Distribution

  • 07290015461047 ()
SET000016

  • Therapeutic oncological/gynaecological ultrasound system

Tap Ø 4.5 for Pendulum Adaptor - 07290115931709

No Description
PREMIA SPINE LTD
87074
In Commercial Distribution

  • 07290115931709 ()


  • Bone tap, reusable

Tap Ø 6.5 for Pendulum Adaptor - 07290115931693

No Description
PREMIA SPINE LTD
86640
In Commercial Distribution

  • 07290115931693 ()


  • Bone tap, reusable

Tap Ø 5.5 for Pendulum Adaptor - 07290115931686

No Description
PREMIA SPINE LTD
86639
In Commercial Distribution

  • 07290115931686 ()


  • Bone tap, reusable

Neuro V2 Kit 3T for USA - 07290015461511

Kit for single use during a Neuro V2 treatment guided under 3T MRI guidance. Kit content: Part Description ASM000355 PATIENT MEMBRANE PACKING ASSY SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET SET400189-AA NEURO TREATMENT ACCESSORIES KIT
INSIGHTEC LTD
SET000960-BB Neuro V2 Kit 3T for USA
In Commercial Distribution

  • 07290015461511 ()
SET000960-BB

  • Therapeutic oncological/gynaecological ultrasound system

Neuro V2 Kit 3T for USA - 07290015461429

Kit for single use during a Neuro V2 treatment guided under 3T MRI guidance. Kit content: Part Description ASM000355 PATIENT MEMBRANE PACKING ASSY SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET SET000961 EXABLATE NEURO CLEANING KIT SET400189-AA NEURO TREATMENT ACCESSORIES KIT
INSIGHTEC LTD
SET000960-AA Neuro V2 Kit 3T for USA
In Commercial Distribution

  • 07290015461429 ()
SET000960-AA

  • Therapeutic oncological/gynaecological ultrasound system

HercepTest™ for Automated Link Plarforms - 05700572032007

HercepTest for Automated Link Platforms
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
SK001
In Commercial Distribution

  • 05700572032007 ()

  • 50 Tests


  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, enzyme immunohistochemistry

HercepTest™ for the Dako Autostainer - 05700572031994

HercepTest for the Dako Autostainer
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
K5207
Not in Commercial Distribution

  • 05700572031994 ()

  • 50 Tests


  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, enzyme immunohistochemistry
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