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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™ - 00191506043049

Recording System Module ECG Trunk Cable
BOSTON SCIENTIFIC CORPORATION
M004PF61M425
In Commercial Distribution

  • 00191506043049 ()
M004PF61M425

  • Electrocardiographic lead set, reusable

FARASTAR™ - 00191506043025

Snap Cable R/L
BOSTON SCIENTIFIC CORPORATION
M004PF61M420
In Commercial Distribution

  • 00191506043025 ()
M004PF61M420

  • Electrocardiographic lead set, reusable

FARASTAR™ - 00191506043001

Snap Cable R/L
BOSTON SCIENTIFIC CORPORATION
M004PF61M418
In Commercial Distribution

  • 00191506043001 ()
M004PF61M418

  • Electrocardiographic lead set, reusable

FARASTAR™ - 00191506042585

Recording System Module Catheter Pin Cable
BOSTON SCIENTIFIC CORPORATION
M004PF61M413
In Commercial Distribution

  • 00191506042585 ()
M004PF61M413

  • Electrical-only medical device connection cable, reusable

FARASTAR™ - 00191506042561

EGM Cable
BOSTON SCIENTIFIC CORPORATION
M004PF61M405
In Commercial Distribution

  • 00191506042561 ()
M004PF61M405

  • Electrical-only medical device connection cable, reusable

FARASTAR™ - 00191506042554

Stimulation Module Cable
BOSTON SCIENTIFIC CORPORATION
M004PF61M404
In Commercial Distribution

  • 00191506042554 ()
M004PF61M404

  • Electrical-only medical device connection cable, reusable

FARASTAR™ - 00191506042509

Recording System Module EGM Input Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M417
In Commercial Distribution

  • 00191506042509 ()
M004PF61M417

  • Electrocardiographic lead set, reusable

FARASTAR™ - 00191506042486

Stimulation Module Y-Cable Long
BOSTON SCIENTIFIC CORPORATION
M004PF61M411
In Commercial Distribution

  • 00191506042486 ()
M004PF61M411

  • 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™ - 00191506052447

Cable Set
BOSTON SCIENTIFIC CORPORATION
M004PF61M499D
In Commercial Distribution

  • 00191506052447 ()
M004PF61M499D

  • Electrocardiographic lead set, reusable
  • Electrical-only medical device connection cable, reusable

FARASTAR™ - 00191506044022

Mapping System Module Auxiliary Cable
BOSTON SCIENTIFIC CORPORATION
M004PF61M408
In Commercial Distribution

  • 00191506044022 ()
M004PF61M408

  • Electrocardiographic lead set, reusable

FARASTAR™ - 00191506044008

Mapping System Module BNC-Phono Cable
BOSTON SCIENTIFIC CORPORATION
M004PF61M605
In Commercial Distribution

  • 00191506044008 ()
M004PF61M605

  • Electrocardiographic lead set, reusable

FARASTAR™ - 00191506043988

Mapping System Module Back Patch Cable
BOSTON SCIENTIFIC CORPORATION
M004PF61M603
In Commercial Distribution

  • 00191506043988 ()
M004PF61M603

  • Electrocardiographic lead set, reusable

FARASTAR™ - 00191506043940

Recording System Module EGM Output to Rhythmia HDx™ EGM Input Cable
BOSTON SCIENTIFIC CORPORATION
M004PF61M422
In Commercial Distribution

  • 00191506043940 ()
M004PF61M422

  • Electrocardiographic lead set, reusable

FARASTAR™ - 00191506043056

Recording System Module ECG Output Module
BOSTON SCIENTIFIC CORPORATION
M004PF61M426
In Commercial Distribution

  • 00191506043056 ()
M004PF61M426

  • Electrocardiographic lead set, reusable

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

FARASTAR™ - 00191506041656

Catheter Connection Cable
BOSTON SCIENTIFIC CORPORATION
M004PF41M434
In Commercial Distribution

  • 00191506041656 ()
M004PF41M434

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

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

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

PulseSelect™ - 00763000617592

CABLE PSCIC101 CATHETER PFA US
MEDTRONIC, INC.
PSCIC101
In Commercial Distribution

  • 00763000617592 ()


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

PulseSelect™ - 00763000617578

CABLE PSEGM100 EGM US
MEDTRONIC, INC.
PSEGM100
In Commercial Distribution

  • 00763000617578 ()


  • Electrical-only medical device connection cable, reusable

PulseSelect™ - 00763000617554

CATHETER PSCC100 PULSESELECT US 25MM
MEDTRONIC, INC.
PSCC100
In Commercial Distribution

  • 00763000617554 ()

  • Tip Outer Diameter 3.25in (9.8 Fr)
  • Electrode Spacing 3.75mm
  • Electrode Length 3.0mm
  • Working Length Outer diameter 3mm (9 Fr)
  • Catheter Working Length: 99.0 Centimeter
  • Loop Outer Diameter 25mm
  • Catheter Length: 145.0 Centimeter


  • Cardiac irreversible electroporation system catheter
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