HBIdb

GUDID 04251341900054

CORSCIENCE GmbH & Co. KG

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