Grass CMXL-E-SPC

GUDID 00382830022323

Comet Plus XL 44-Channel Digital EEG Record & Review System

XLTEK

Electroencephalograph

• Primary Device ID: 00382830022323
• NIH Device Record Key: 95f9cfaf-44f3-458d-8351-471f0ddaf2ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grass
• Version Model Number: CMXL-E-SPC
• Catalog Number: CMXL-E-SPC
• Company DUNS: 245258280
• Company Name: XLTEK
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830022323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172711

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: 2018-08-13
• Device Publish Date: 2018-07-13

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• 00382830022415: CometXL-Plus 57-Channel Digital PSG Record & Review System
• 00382830022408: CometXL-Plus 57-Channel Digital PSG Record & Review System
• 00382830022392: CometXL-Plus 57-Channel Digital PSG Record & Review System
• 00382830022347: Comet Plus XL 44-Channel Digital EEG Record & Review System
• 00382830022330: Comet Plus XL 44-Channel Digital EEG Record & Review System
• 00382830022323: Comet Plus XL 44-Channel Digital EEG Record & Review System
• 00382830022316: Comet Plus XL 44-Channel Digital EEG Record & Review System