| Primary Device ID | 07290107982016 |
| NIH Device Record Key | 8021813f-c601-4d50-bdcb-516cce696b59 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Battery for Optune |
| Version Model Number | IBH9100 |
| Catalog Number | IBH9100US |
| Company DUNS | 532457256 |
| Company Name | NOVOCURE (ISRAEL) LTD |
| 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 | 07290107982016 [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 |