HBIdb

GUDID 04251341900054

CORSCIENCE GmbH & Co. KG

Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software

• Primary Device ID: 04251341900054
• NIH Device Record Key: d5ae0c91-3551-4c59-9135-aa8ef0271073
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HBIdb
• Version Model Number: CS20401
• Company DUNS: 333427776
• Company Name: CORSCIENCE GmbH & Co. KG
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251341900054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112077

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

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: 2022-03-18
• Device Publish Date: 2022-03-10

Devices Manufactured by CORSCIENCE GmbH & Co. KG

• 04251341900252 - COR12: 2023-05-05
• 04251341900054 - HBIdb: 2022-03-18
• 04251341900054 - HBIdb: 2022-03-18
• 04251341900344 - COR12: 2021-07-09
• 04251341900108 - COR12: 2019-11-27
• 04251341900238 - GoECG: 2019-03-11
• 04251341900245 - GoECG: 2019-03-11
• 04251341900115 - COR12: 2019-02-25
• 04251341900016 - EEG NeuroAmp II: 2018-07-06