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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ExAblate 2100V1 PHASE ARRAY ASSY Pelvic RF Coil for 1.5T MRI imaging during Body FUS treatments. Contains Upper and Lower part: ASM000426-AA - UPPER PELVIC COIL PHASE ARRAY ASSY ASC001361 - LOWER PELVIC COIL PHASE ARRAY ASSY for ExAblate 2100V1
INSIGHTEC LTD
OPT000037 ExAblate 2100V1 Pelvic RF Coil for Body
In Commercial Distribution

  • 07290015461474 ()
OPT000037

  • Therapeutic oncological/gynaecological ultrasound system
ExAblate 2100V1 LOWER PELVIC COIL for 1.5T GE ARTIST MR guided FUS Body (uterine fibroids, bone mets) treatments
INSIGHTEC LTD
ASC001361-AR ExAblate 2100V1 LOWER PELVIC COIL ASSEMBLY ARTIST
In Commercial Distribution

  • 07290015461467 ()
ASC001361-AR

  • Therapeutic oncological/gynaecological ultrasound system
ExAblate 2100V1 LOWER PELVIC RF COIL for 1.5T MR guided FUS Body (Uterine fibroids, bone mets) treatments
INSIGHTEC LTD
ASC001361 ExAblate 2100V1 LOWER PELVIC COIL
In Commercial Distribution

  • 07290015461450 ()
ASC001361

  • Therapeutic oncological/gynaecological ultrasound system
patient plastic drape to accomodate degassed water and gel pad in a MR-guided FUS treatment. a part of UF/Bone1 treatment kit (SET000016)
INSIGHTEC LTD
Patient plastic drape
In Commercial Distribution

  • 07290015461269 ()
DTP000067

  • Therapeutic oncological/gynaecological ultrasound system
1 liter degassed water pouch for use in UF and Bone1 MR-guided FUS treatment for good ultrasound beam transmission. a part of UF/Bone 1 treatment kit (SET000016)
INSIGHTEC LTD
1L degasseed water pouch
In Commercial Distribution

  • 07290015461252 ()
ASM001480

  • Therapeutic oncological/gynaecological ultrasound system
Tissue mimic phantom gel for DQA for Body applications
INSIGHTEC LTD
DQA phantom Body
In Commercial Distribution

  • 07290015461214 ()
SET000885

  • Therapeutic oncological/gynaecological ultrasound system
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
Transmission gel pad for single Body treatment. shipped in the following thickness (height) variants: Description Catalogue Number GEL PAD UF 25MM ASSY ASM000352-AA GEL PAD 15MM ASSY ASM000830-AA GEL PAD 40MM ASSY(Step) ASM002213 GEL PAD 45MM ASSY(Bowl) ASM000504-AA
INSIGHTEC LTD
Gel Pad ASSY
In Commercial Distribution

  • 07290015461085 ()

  • Height: 45 Millimeter
  • Height: 40 Millimeter
  • Height: 25 Millimeter
  • Height: 15 Millimeter
SET999014

  • Therapeutic oncological/gynaecological ultrasound system
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
CORD PWC101 POWER CORD NORTH AMERICA
MEDTRONIC, INC.
PWC101
In Commercial Distribution

  • 00763000642082 ()


  • Electrical mains power cable
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