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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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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

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

Grounding Pads - 00850014433161

A grounding pad is placed on the body (usually the thigh) before the surgery to protect the person from the harmful effects of the electricity.
DISTRIBUTION UNLIMITED, LLC
1
In Commercial Distribution

  • 10850014433168 ()
  • 00850014433161 ()
  • 20850014433165 ()
DU2100

  • Electrosurgical return electrode, single-use

SureGuide - 00850013050185

SureGuide, 2.75m Fiber Cable Assembly, ST Connector
Clinicon Corporation
4143
In Commercial Distribution

  • 00850013050185 ()


  • General/multiple surgical laser system beam guide, single-use

SureGuide - 00850013050178

SureGuide, 2.75m Fiber Cable Assembly,SMA with Interlock Wire
Clinicon Corporation
3156
In Commercial Distribution

  • 00850013050178 ()


  • General/multiple surgical laser system beam guide, single-use

SureGuide - 00850013050161

SureGuide, 2.00m Fiber Cable Assembly, ST Connector
Clinicon Corporation
4140
In Commercial Distribution

  • 00850013050161 ()


  • General/multiple surgical laser system beam guide, single-use
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