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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™ - 00191506042479

Stimulation Module Female Cable
BOSTON SCIENTIFIC CORPORATION
M004PF61M410
In Commercial Distribution

  • 00191506042479 ()
M004PF61M410

  • Electrical-only medical device connection cable, reusable

FARASTAR™ - 00191506042462

Stimulation Module Male Cable
BOSTON SCIENTIFIC CORPORATION
M004PF61M409
In Commercial Distribution

  • 00191506042462 ()
M004PF61M409

  • Electrical-only medical device connection cable, reusable

FARASTAR™ - 00191506041663

Catheter Connection Cable
BOSTON SCIENTIFIC CORPORATION
M004PF41M444
In Commercial Distribution

  • 00191506041663 ()
M004PF41M444

  • Electrical-only medical device connection cable, single-use

FARASTAR™ - 00191506041656

Catheter Connection Cable
BOSTON SCIENTIFIC CORPORATION
M004PF41M434
In Commercial Distribution

  • 00191506041656 ()
M004PF41M434

  • Electrical-only medical device connection cable, single-use

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 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

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
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