Zipshield 5m 31-0604-0128

GUDID 00850011306963

This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily applied over one or more ATLAS Tether cables providing both noise shielding and cable management.

NEURALYNX, INC.

Facility radio-frequency shielding material

• Primary Device ID: 00850011306963
• NIH Device Record Key: 015932db-c4ff-467a-a099-0352ce01faa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zipshield 5m
• Version Model Number: 5m
• Catalog Number: 31-0604-0128
• Company DUNS: 933200842
• Company Name: NEURALYNX, INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011306963 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110967

FDA Product Code

• OMC: Reduced- 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: 2024-12-19
• Device Publish Date: 2024-12-11

Devices Manufactured by NEURALYNX, INC.

• 00850011306932 - ATLAS Workstation Monitor: 2024-12-26 The ATLAS Workstation Monitor connects to the ATLAS Workstation (31-0004-0000).
• 00850011306949 - ATLAS Workstation: 2024-12-26 The ATLAS Workstation is a computer that runs the Data Acquisition Software.
• 00850011306956 - ATLAS Parallel TTL Cable: 2024-12-26 The Parallel TTL Cable is a ribbon cable that connects 25 pin computer parallel port to the digital I/O port on the ATLAS System
• 00850011306239 - ATLAS Rackmounted Power Isolator: 2024-12-19 An uninterruptible power supply that provides power to the ATLAS Neurophysiology System for up to five minutes and limits patien
• 00850011306253 - Ethernet Switch: 2024-12-19 The Ethernet Switch is a fully managed switch designed for high-performance networking in enterprise environments.
• 00850011306963 - Zipshield 5m: 2024-12-19This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily applied over one or more ATLAS Tether cables providing both noise shielding and cable management.
• 00850011306963 - Zipshield 5m: 2024-12-19 This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily appl
• 00850011306970 - Zipshield 10m: 2024-12-19 This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily appl
• 00850011306987 - ATLAS Power Isolator 110VAC: 2024-12-19 An uninterruptible power supply that provides power to the ATLAS Neurophysiology System for up to five minutes and limits patien