Nicolet

GUDID 00382830058094

UltraPro S100 Main Base Unit

NATUS NEUROLOGY INCORPORATED

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• Primary Device ID: 00382830058094
• NIH Device Record Key: cfb256ae-56f9-4a36-99ee-24eb2d79f47d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nicolet
• Version Model Number: 9033UP704
• Company DUNS: 874257488
• Company Name: NATUS NEUROLOGY INCORPORATED
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830058094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130346

FDA Product Code

• GWF: Stimulator, Electrical, Evoked Response

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: 2020-11-30
• Device Publish Date: 2020-11-20

On-Brand Devices [Nicolet]

• 00382830059220: UltraPro S100 4 Channel Amplifier
• 00382830059213: UltraPro S100 3 Channel Amplifier
• 00382830058094: UltraPro S100 Main Base Unit