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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 3.0T SI SU - 07290019402138

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 - 07290019402121

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

HEAD FRAME SET FOR TYPE 1.1 SYSTEMS (R20) - 07290015461948

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) - 07290015461931

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 - 07290015461924

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) - 07290015461917

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

Master Treatment Kit for 3.0T (SIEMENS) Type 1.1 NonCE/FDA - 07290015461900

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

Master Treatment Kit for 1.5T (SIEMENS) Type 1.1 NonCE/FDA - 07290015461894

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

Master Treatment Kit for 3.0T (GE) Type 1.0& 1.1 NonCE/FDA - 07290015461887

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

Master Treatment Kit for 1.5T (GE) Type 1.0 NonCE/FDA - 07290015461870

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
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