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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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neuro membrane for a FUS brain treatment to hold degassed water between transducer and skull. included in 3T Neuro kit for USA (SET000936)
INSIGHTEC LTD
neuro membrane
In Commercial Distribution

  • 07290015461177 ()
ASM000355

  • Therapeutic oncological/gynaecological ultrasound system
System for non-invasive tumor ablation within head through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS) for Siemens MRI scanners.
INSIGHTEC LTD
SYS0004000-BA 4000 Type 1.1
In Commercial Distribution

  • 07290015461092 ()

  • Weight: 1700 Kilogram
EXABLATE 4000 Type 1.1

  • Therapeutic oncological/gynaecological ultrasound system
COMMUNICATOR 8880T2 TELEM MOD EMAN US EN
MEDTRONIC, INC.
8880T2
In Commercial Distribution

  • 00763000420994 ()


  • Multiple active implantable device programmer
Surgical Instrument Kit Hammer System
Integrum AB
2712
In Commercial Distribution

  • 07340152102379 ()


  • Internal-external leg prosthesis osseointegration bar
Surgical Instrument Guide pin used during OPRA™ Fixture removal. Provides a guiding system to centre the Trephine aligned to the Fixture when used together with Guide Sleeve.
Integrum AB
2617
In Commercial Distribution

  • 07340152102225 ()


  • Internal-external leg prosthesis osseointegration bar
Drill-bit 11,7 mm
Integrum AB
2590
In Commercial Distribution

  • 07340152102218 ()


  • Internal-external leg prosthesis osseointegration bar
Abutment 12x78 +10
Integrum AB
2600
In Commercial Distribution

  • 07340152102201 ()


  • Internal-external leg prosthesis osseointegration bar
Abutment 12x78 +9
Integrum AB
2599
In Commercial Distribution

  • 07340152102195 ()


  • Internal-external leg prosthesis osseointegration bar
Abutment 12x78 +8
Integrum AB
2598
In Commercial Distribution

  • 07340152102188 ()


  • Internal-external leg prosthesis osseointegration bar
Abutment 12x78 +7
Integrum AB
2597
In Commercial Distribution

  • 07340152102171 ()


  • Internal-external leg prosthesis osseointegration bar
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