Primary Device ID | 07290107981590 |
NIH Device Record Key | ece19d09-ff8d-4f9e-815c-4744da5a6f2b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Battery for Optune |
Version Model Number | IBH9100 |
Catalog Number | IBH9100US |
Company DUNS | 486647295 |
Company Name | Novocure GmbH |
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 | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
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 |
Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from extreme heat and sources of radiation |
Special Storage Condition, Specify | Between 0 and 0 *Fragile - handle with care |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *WEEE |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07290107981590 [Primary] |
NZK | Stimulator, Low Electric Field, Tumor Treatment |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-09-05 |
Device Publish Date | 2018-08-05 |
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