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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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FARASTAR™ - 00191506043032

Snap Cable C Set
BOSTON SCIENTIFIC CORPORATION
M004PF61M421
In Commercial Distribution

  • 00191506043032 ()
M004PF61M421

  • Electrocardiographic lead set, reusable

FARASTAR™ - 00191506043018

Snap Cable V Set
BOSTON SCIENTIFIC CORPORATION
M004PF61M419
In Commercial Distribution

  • 00191506043018 ()
M004PF61M419

  • Electrocardiographic lead set, reusable

FARASTAR™ - 00191506042998

Recording System Module ECG Output Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M416
In Commercial Distribution

  • 00191506042998 ()
M004PF61M416

  • Electrocardiographic lead set, reusable

FARASTAR™ - 00191506042981

Recording System Module ECG Trunk Cable
BOSTON SCIENTIFIC CORPORATION
M004PF61M415
In Commercial Distribution

  • 00191506042981 ()
M004PF61M415

  • Electrocardiographic lead set, reusable

FARASTAR™ - 00191506042493

Stimulation Module Y-Cable Short
BOSTON SCIENTIFIC CORPORATION
M004PF61M412
In Commercial Distribution

  • 00191506042493 ()
M004PF61M412

  • Electrical-only medical device connection cable, reusable

FARASTAR™ - 00191506042479

Stimulation Module Female Cable
BOSTON SCIENTIFIC CORPORATION
M004PF61M410
In Commercial Distribution

  • 00191506042479 ()
M004PF61M410

  • Electrical-only medical device connection cable, reusable

ExAblate 2100V1 Pelvic RF Coil for 1.5T Artist MR - 07290015461481

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 ASC001361-AR - LOWER PELVIC COIL PHASE ARRAY ASSY for ExAblate 2100V1 under Artist MR guidance
INSIGHTEC LTD
OPT000037-AR ExAblate 2100V1 Pelvic RF Coil for Body
In Commercial Distribution

  • 07290015461481 ()
OPT000037-AR

  • Therapeutic oncological/gynaecological ultrasound system

Patient plastic drape - 07290015461269

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

1L degasseed water pouch - 07290015461252

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

Exablate DQA Phantom Gel - 07290015461214

Tissue mimic phantom gel for DQA for Body applications
INSIGHTEC LTD
DQA phantom Body
In Commercial Distribution

  • 07290015461214 ()
SET000885

  • Therapeutic oncological/gynaecological ultrasound system
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