water bag kit SET000840

GUDID 07290015461054

water bag kit for ultrasound good transmission in bone 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 ID07290015461054
NIH Device Record Key586ac2fd-4bd0-46b1-a681-439ca659f90a
Commercial Distribution StatusIn Commercial Distribution
Brand Namewater bag kit
Version Model Numberwater bag kit
Catalog NumberSET000840
Company DUNS532169513
Company NameINSIGHTEC LTD
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
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

Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290015461054 [Primary]

FDA Product Code

LSYUltrasound,Hyperthermia, Cancer Treatment
NRZAblation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

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 Date2017-06-07

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