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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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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

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

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™ - 00191506044015

Mapping System Module Rhythmia™ ABL Cable
BOSTON SCIENTIFIC CORPORATION
M004PF61M606
In Commercial Distribution

  • 00191506044015 ()
M004PF61M606

  • 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™ - 00191506043995

Mapping System Module Back Patch Cable Male
BOSTON SCIENTIFIC CORPORATION
M004PF61M604
In Commercial Distribution

  • 00191506043995 ()
M004PF61M604

  • 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™ - 00191506043957

Recording System Module ECG Output to Rhythmia HDx™ ECG Input Cable
BOSTON SCIENTIFIC CORPORATION
M004PF61M423
In Commercial Distribution

  • 00191506043957 ()
M004PF61M423

  • 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™ - 00191506043049

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

  • 00191506043049 ()
M004PF61M425

  • Electrocardiographic lead set, reusable
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