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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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EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE SU w/PFK for 1 treatment for GE MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001114-SU (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE SU
In Commercial Distribution

  • 07290019402152 ()
SET001114-SU

  • Therapeutic oncological/gynaecological ultrasound system
EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE w/PFK for 5 treatments for GE MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001114 (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE
In Commercial Distribution

  • 07290019402145 ()
SET001114

  • Therapeutic oncological/gynaecological ultrasound system
EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI w/PFK for 1 treatment for Siemens MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001113-SU (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI
In Commercial Distribution

  • 07290019402138 ()
SET001113-SU

  • Therapeutic oncological/gynaecological ultrasound system
EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI w/PFK for 5 treatments for Siemens MR PFK package served ETO-sterile
INSIGHTEC LTD
SET001113 (w/ PFK) EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI
In Commercial Distribution

  • 07290019402121 ()
SET001113

  • Therapeutic oncological/gynaecological ultrasound system
A Kit for 10 Neuro treatments (Master Treatment Kit for 3.0T (SIEMENS) Type 1.1 NonCE/FDA) Kit content: Part Description SET001047 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI (5) X 2 units
INSIGHTEC LTD
SET001104 Master Treatment Kit for 3.0T (SIEMENS) Type 1.1 NonCE/FDA
In Commercial Distribution

  • 07290015461900 ()
SET001104

  • Therapeutic oncological/gynaecological ultrasound system
A Kit for 10 Neuro treatment (Master Treatment Kit for 1.5T (SIEMENS) Type 1.1 NonCE/FDA). Kit content: Part Description SET001046 EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI (5) X 2 units
INSIGHTEC LTD
SET001103 Master Treatment Kit for 1.5T (SIEMENS) Type 1.1 NonCE/FDA
In Commercial Distribution

  • 07290015461894 ()
SET001103

  • Therapeutic oncological/gynaecological ultrasound system
A Kit for 10 Neuro treatment (Master Treatment Kit for 3.0T (GE) Type 1.0& 1.1 NonCE/FDA). Kit content: Part Description SET001045 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE (5) X 2 units
INSIGHTEC LTD
SET001102 Master Treatment Kit for 3.0T (GE) Type 1.0& 1.1 NonCE/FDA
In Commercial Distribution

  • 07290015461887 ()
SET001102

  • Therapeutic oncological/gynaecological ultrasound system
A Kit for 10 Neuro treatment (Master Treatment Kit for 1.5T (GE) Type 1.0 NonCE/FDA) Kit content: Part Description SET001044 EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE (5) X 2 units
INSIGHTEC LTD
SET001101 Master Treatment Kit for 1.5T (GE) Type 1.0 NonCE/FDA
In Commercial Distribution

  • 07290015461870 ()
SET001101

  • Therapeutic oncological/gynaecological ultrasound system
Kit for 10 Neuro treatments Kit content: Part Description SET001043 EX NEURO PATIENT TREATMENT KIT 3.0T W\O COIL (5) X 2 units
INSIGHTEC LTD
SET001100 Master Treatment Kit for 3.0T w\o Headcoil, Type 1.0& 1.1 NonCE/FDA
In Commercial Distribution

  • 07290015461863 ()
SET001100

  • Therapeutic oncological/gynaecological ultrasound system
A Kit for 5 Neuro treatment used under 3T MRI guidance. Kit content: Part Description SET400314 Neuro kit 3T US MPR000444-AA HEAD RING SCREWS LONG SET (sterile)
INSIGHTEC LTD
SET001025 MASTER SET NEURO-V1 3T TREAT. KITS (5 X SET400314)
In Commercial Distribution

  • 07290015461566 ()
SET001025

  • Therapeutic oncological/gynaecological ultrasound system
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