INE Transducer Array Black Connector INE9000

GUDID 07290107981699

NOVOCURE INC.

Alternating electric field antimitotic cancer treatment system transducer array
Primary Device ID07290107981699
NIH Device Record Keydd51602b-ba64-40c7-9f53-84f424e7ee9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameINE Transducer Array Black Connector
Version Model NumberINE9000
Catalog NumberINE9000
Company DUNS056552035
Company NameNOVOCURE INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Phone1-855-281-9301
Emailsupport@novocure.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE

Device Identifiers

Device Issuing AgencyDevice ID
GS107290000000004 [Primary]
GS107290107981699 [Package]
Contains: 07290107983372
Package: Carton Box [20 Units]
In Commercial Distribution
GS107290107983372 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NZKStimulator, Low Electric Field, Tumor Treatment

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[07290107981699]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-13
Device Publish Date2015-09-20

Devices Manufactured by NOVOCURE INC.

07290107983297 - INE Transducer Arrays Tan Plaster and Black Connector2021-02-10
07290107982825 - ILE Transducer Arrays Small White Connector2020-12-17
07290107982832 - ILE Transducer Arrays Large White Connector2020-12-17
07290107982863 - Power Supply for NovoTTF-100L 2020-12-17
07290107982818 - ILE Transducer Arrays Small Black Connector2020-12-16
07290107982955 - Portable Battery for NovoTTF-100L2020-12-16
07290107982986 - Connection Cable for NovoTTF-100L2020-12-16
07290107982856 - NovoTTF-100L2020-12-15

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