| Primary Device ID | 07290107985185 |
| NIH Device Record Key | 953d00a9-688d-4a85-964c-10d9d15bcdd8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INE Transducer Arrays Tan Plaster and Black Connector |
| Version Model Number | INE9TAN |
| Catalog Number | INE9020US |
| Company DUNS | 552446858 |
| Company Name | FLEXTRONICS ROMANIA SRL |
| Device Count | 20 |
| 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 | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | 07290107983839 [Primary] |
| GS1 | 07290107985185 [Unit of Use] |
| NZK | Stimulator, Low Electric Field, Tumor Treatment |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[07290107985185]
Radiation Sterilization
[07290107985185]
Radiation Sterilization
[07290107985185]
Radiation Sterilization
[07290107985185]
Radiation Sterilization
[07290107985185]
Radiation Sterilization
[07290107985185]
Radiation Sterilization
[07290107985185]
Radiation Sterilization
[07290107985185]
Radiation Sterilization
[07290107985185]
Radiation Sterilization
[07290107985185]
Radiation Sterilization
[07290107985185]
Radiation Sterilization
[07290107985185]
Radiation Sterilization
[07290107985185]
Radiation Sterilization
[07290107985185]
Radiation Sterilization
[07290107985185]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-17 |
| Device Publish Date | 2021-02-09 |
| 07290107985185 - INE Transducer Arrays Tan Plaster and Black Connector | 2021-02-17 |
| 07290107985185 - INE Transducer Arrays Tan Plaster and Black Connector | 2021-02-17 |
| 07290107985192 - INE Transducer Arrays Tan Plaster and White Connector | 2021-02-12 |