Neon8 KIT

GUDID 05391530950121

Neon8 KIT version, packaged without electrode paste or skin prep gel

INCEREB LIMITED

Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use

• Primary Device ID: 05391530950121
• NIH Device Record Key: 0c5bcd12-935b-421a-9048-92ef3928eb11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neon8 KIT
• Version Model Number: TF04K
• Company DUNS: 985065024
• Company Name: INCEREB LIMITED
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391530950107 [Primary]
GS1	05391530950121 [Package]; Contains: 05391530950107; Package: Box [5 Units]; In Commercial Distribution
GS1	05391530950145 [Package]; Package: Shipper box [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151576

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-01
• Device Publish Date: 2022-03-24

Devices Manufactured by INCEREB LIMITED

• 05391530950091 - Neon 12 KIT: 2022-04-01 Kit version of neon12, packaged without electrode paste or skin prep gel
• 05391530950121 - Neon8 KIT: 2022-04-01Neon8 KIT version, packaged without electrode paste or skin prep gel
• 05391530950121 - Neon8 KIT: 2022-04-01 Neon8 KIT version, packaged without electrode paste or skin prep gel
• 05391530950084 - neon8: 2022-01-24 EEG electrode array sized for use with neonatal infants. The array has qty 8 electrodes. The device is single use only. This
• 05391530950022 - neon12: 2018-07-06 EEG electrode array sized for use with neonatal infants. The array has qty 12 electrodes. The device is single use only
• 05391530950053 - neon8: 2018-07-06 EEG electrode array sized for use with neonatal infants. The array has qty 8 electrodes. The device is single use only