ExAblate 2100V1 Pelvic RF Coil 1.5T OPT000037

GUDID 07290015461474

ExAblate 2100V1 PHASE ARRAY ASSY Pelvic RF Coil for 1.5T MRI imaging during Body FUS treatments. Contains Upper and Lower part: ASM000426-AA - UPPER PELVIC COIL PHASE ARRAY ASSY ASC001361 - LOWER PELVIC COIL PHASE ARRAY ASSY for ExAblate 2100V1

INSIGHTEC LTD

Therapeutic oncological/gynaecological ultrasound system
Primary Device ID07290015461474
NIH Device Record Keyf9e494ea-c6e0-4bae-8ba4-6986f361fc2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameExAblate 2100V1 Pelvic RF Coil 1.5T
Version Model NumberOPT000037 ExAblate 2100V1 Pelvic RF Coil for Body
Catalog NumberOPT000037
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 Numbertrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -15 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290015461474 [Primary]

FDA Product Code

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 Number2
Public Version Date2019-11-08
Device Publish Date2018-11-29

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