RNS® Neurostimulator Kit

GUDID 00855547005120

The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cover, 1 Ferrule, 1 Ferrule Clamp, 1 Lead Strain Relief and 1 Torque Driver.

Neuropace, Inc.

Brain-responsive electrical stimulation system

• Primary Device ID: 00855547005120
• NIH Device Record Key: 7ba9a828-bdb3-4d59-9b78-c1115f3d4819
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RNS® Neurostimulator Kit
• Version Model Number: RNS-300M-K
• Company DUNS: 123369238
• Company Name: Neuropace, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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: +1(866)726-3876
• Email: customerservice@neuropace.com
• Phone: +1(866)726-3876
• Email: customerservice@neuropace.com
• Phone: +1(866)726-3876
• Email: customerservice@neuropace.com
• Phone: +1(866)726-3876
• Email: customerservice@neuropace.com
• Phone: +1(866)726-3876
• Email: customerservice@neuropace.com
• Phone: +1(866)726-3876
• Email: customerservice@neuropace.com
• Phone: +1(866)726-3876
• Email: customerservice@neuropace.com
• Phone: +1(866)726-3876
• Email: customerservice@neuropace.com
• Phone: +1(866)726-3876
• Email: customerservice@neuropace.com
• Phone: +1(866)726-3876
• Email: customerservice@neuropace.com
• Phone: +1(866)726-3876
• Email: customerservice@neuropace.com
• Phone: +1(866)726-3876
• Email: customerservice@neuropace.com
• Phone: +1(866)726-3876
• Email: customerservice@neuropace.com
• Phone: +1(866)726-3876
• Email: customerservice@neuropace.com
• Phone: +1(866)726-3876
• Email: customerservice@neuropace.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855547005120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100026

FDA Product Code

• PFN: Implanted brain stimulator for epilepsy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-18

On-Brand Devices [RNS® Neurostimulator Kit]

• 00855547005267: The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cove
• 00855547005120: The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cove
• 00855547005366: The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cove