NeuroPace® Remote Monitor Kit

GUDID 00855547005434

The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, and 1 Carrying Case.

Neuropace, Inc.

Brain-responsive electrical stimulation system

• Primary Device ID: 00855547005434
• NIH Device Record Key: a7785849-c471-407d-a47c-d4054c85bed2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroPace® Remote Monitor Kit
• Version Model Number: 5107
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: +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
• Phone: +1(866)726-3876
• Email: customerservice@neuropace.com
• Phone: +1(866)726-3876
• Email: customerservice@neuropace.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855547005427 [Primary]
GS1	00855547005434 [Direct Marking]

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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-22
• Device Publish Date: 2023-11-14

On-Brand Devices [NeuroPace® Remote Monitor Kit]

• 00855547005243: The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case, 1
• 00855547005182: The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case an
• 00855547005199: The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case, 1
• 00855547005434: The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, and 1 Carrying Cas