Neuro Stereotactic Frame Screws Set MPR001138

GUDID 07290015461313

spare screws for neuro stereotactic frame for use during neuro FUS clinical treatment

INSIGHTEC LTD

Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system Therapeutic oncological/gynaecological ultrasound system
Primary Device ID07290015461313
NIH Device Record Key4e90c652-cc43-45b1-a0e1-5e7b07359596
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuro Stereotactic Frame Screws Set
Version Model NumberNeuro Stereotactic Frame Screws Set
Catalog NumberMPR001138
Company DUNS532169513
Company NameINSIGHTEC LTD
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18663922528
Emailinfo@insightec.com
Phone18663922528
Emailinfo@insightec.com
Phone18663922528
Emailinfo@insightec.com
Phone18663922528
Emailinfo@insightec.com
Phone18663922528
Emailinfo@insightec.com
Phone18663922528
Emailinfo@insightec.com
Phone18663922528
Emailinfo@insightec.com
Phone18663922528
Emailinfo@insightec.com
Phone18663922528
Emailinfo@insightec.com
Phone18663922528
Emailinfo@insightec.com
Phone18663922528
Emailinfo@insightec.com
Phone18663922528
Emailinfo@insightec.com
Phone18663922528
Emailinfo@insightec.com
Phone18663922528
Emailinfo@insightec.com
Phone18663922528
Emailinfo@insightec.com
Phone18663922528
Emailinfo@insightec.com
Phone18663922528
Emailinfo@insightec.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290015461313 [Primary]

FDA Product Code

LSYUltrasound,Hyperthermia, Cancer Treatment
POHMr-Guided Focused Ultrasound System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2017-07-31

Devices Manufactured by INSIGHTEC LTD

07290019402442 - HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI)2023-07-04 HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI). Multi use Stereotactic Frame Set for fixing the skull position during neuro FUS cl
07290019402466 - HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI)2023-07-04 HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI). Multi use Stereotactic Frame Set for fixing the skull position during neuro FUS cl
07290019402121 - EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI2023-06-22 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI w/PFK for 5 treatments for Siemens MR PFK package served ETO-sterile
07290019402138 - EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI SU2023-06-22 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI w/PFK for 1 treatment for Siemens MR PFK package served ETO-sterile
07290019402145 - EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE2023-06-22 EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE w/PFK for 5 treatments for GE MR PFK package served ETO-sterile
07290019402152 - EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI SU2023-06-22 EXABLATE NEURO PATIENT TREATMENT KIT 1.5T GE SU w/PFK for 1 treatment for GE MR PFK package served ETO-sterile
07290019402169 - EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE2023-06-22 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE w/PFK for 5 treatments for GE MR PFK package served ETO-sterile
07290019402176 - EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE SU2023-06-22 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE SU w/PFK for 1 treatment for GE MR PFK package served ETO-sterile

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.