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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HEAD FRAME SET FOR TYPE 1.1 SYSTEMS (R20). multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment
INSIGHTEC LTD
SET400168-BB HEAD FRAME SET FOR TYPE 1.1 SYSTEMS (R20)
In Commercial Distribution

  • 07290015461948 ()
SET400168-BB

  • Therapeutic oncological/gynaecological ultrasound system
HEAD FRAME SET FOR TYPE 1.0 SYSTEMS (R20). multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment
INSIGHTEC LTD
SET400168-BA HEAD FRAME SET FOR TYPE 1.0 SYSTEMS (R20)
In Commercial Distribution

  • 07290015461931 ()
SET400168-BA

  • Therapeutic oncological/gynaecological ultrasound system
INSIGHTEC HEAD FRAME+INTEGRA PINS 1.0 SET. multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment
INSIGHTEC LTD
SET400168-AB INSIGHTEC HEAD FRAME+INTEGRA PINS 1.0 SET
In Commercial Distribution

  • 07290015461924 ()
SET400168-AB

  • Therapeutic oncological/gynaecological ultrasound system
Low Height Head Frame Set NEURO-V2 (Inegra). multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment
INSIGHTEC LTD
SET400168-AA Low Height Head Frame Set NEURO-V2 (Inegra)
In Commercial Distribution

  • 07290015461917 ()
SET400168-AA

  • 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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