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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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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

Gel Pad ASSY - 07290015461085

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

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

ExAblate 2100/2100V1/2100V1-AR UPPER PELVIC COIL - 07290015461504

ExAblate 2100/2100V1/2100V1-AR UPPER PELVIC COIL for MRI imaging during Body FUS treatments. Contains Upper and Lower part:
INSIGHTEC LTD
ASM000426-AA ExAblate 2100/2100V1/2100V1-AR UPPER PELVIC COIL
In Commercial Distribution

  • 07290015461504 ()
ASM000426-AA

  • Therapeutic oncological/gynaecological ultrasound system

ExAblate 2100 LOWER PELVIC COIL ASSEMBLY - 07290015461498

ExAblate 2100 LOWER PELVIC COIL ASSEMBLY for MRI imaging during Body FUS treatments.
INSIGHTEC LTD
ASM000506-AA ExAblate 2100 LOWER PELVIC COIL ASSEMBLY
In Commercial Distribution

  • 07290015461498 ()
ASM000506-AA

  • Therapeutic oncological/gynaecological ultrasound system

ExAblate 2100V1 Pelvic RF Coil 1.5T - 07290015461474

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 ASSEMBLY ARTIST 1.5T - 07290015461467

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 COIL 1.5T - 07290015461450

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

NA - 00763000642082

CORD PWC101 POWER CORD NORTH AMERICA
MEDTRONIC, INC.
PWC101
In Commercial Distribution

  • 00763000642082 ()


  • Electrical mains power cable

PulseSelect™ - 00763000617783

FOOTSWITCH PSFS100 PFA US
MEDTRONIC, INC.
PSFS100
In Commercial Distribution

  • 00763000617783 ()


  • Foot-switch, electrical
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