HEAD RING SCREWS LONG MPR000444-AA

GUDID 07290015461368

Single use screws connecting stereotactic frame with patient skull during neuro MRI guided FUS treatment.

INSIGHTEC LTD

Therapeutic oncological/gynaecological ultrasound system
Primary Device ID07290015461368
NIH Device Record Key7dd7cf10-651d-4a10-9c99-7260a7eb4edd
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEAD RING SCREWS LONG
Version Model NumberMPR000444-AA HEAD RING SCREWS LONG SET
Catalog NumberMPR000444-AA
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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

Storage 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
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290015461368 [Primary]

FDA Product Code

POHMr-Guided Focused Ultrasound System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-08
Device Publish Date2018-06-07

On-Brand Devices [HEAD RING SCREWS LONG]

07290015461368Single use screws connecting stereotactic frame with patient skull during neuro MRI guided FUS t
07290015461221Ong single use screws connecting stereotactic frame with patient skull during neuro MRI guided F

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