Primary Device ID | 07290000000007 |
NIH Device Record Key | d13a4e34-67b7-4a4a-a40e-8316c1180a6e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | INE Transducer Arrays White Connector |
Version Model Number | INE9000W |
Catalog Number | INE9000W |
Company DUNS | 079342722 |
Company Name | INTEGRA BIOTECHNICAL LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-855-281-9301 |
support@novocure.com |
Special Storage Condition, Specify | Between 0 and 0 *WEEE |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Fragile - handle with care |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from extreme heat and sources of radiation |
Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07290000000007 [Primary] |
GS1 | 07290107981798 [Package] Package: Carton Box [20 Units] In Commercial Distribution |
NZK | Stimulator, Low Electric Field, Tumor Treatment |
Steralize Prior To Use | true |
Device Is Sterile | true |
[07290000000007]
Radiation Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2015-09-20 |
07290000000007 | INE9000W |
07290107983396 | INE9000W |