NeuroPace® Programmer Kit

GUDID 00855547005212

The NeuroPace® Programmer package contains 1 NeuroPace® Programmer and 1 Carrying Case.

Neuropace, Inc.

Brain-responsive electrical stimulation system

• Primary Device ID: 00855547005212
• NIH Device Record Key: 3c46d142-b3e3-4422-873b-0d3473b7949e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroPace® Programmer Kit
• Version Model Number: PGM-300-K
• Company DUNS: 123369238
• Company Name: Neuropace, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855547005106 [Primary]
GS1	00855547005212 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

Devices Manufactured by Neuropace, Inc.

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• 00855547005410 - Explant Kit: 2022-03-02 The Explant Kit package contains 2 Lead Caps and 1 Torque Driver.
• 00855547005403 - Remote Monitor Phone Accessories: 2020-09-22 The NeuroPace® Remote Monitor Phone Accessories package contains 1 External Modem, 1 Telephone Cord, 1 Telephone Line Splitter.
• 00855547005373 - Ferrule Kit: 2020-03-24 The Ferrule package contains 1 Ferrule, 1 Ferrule Clamp and 1 Torque Driver.
• 00855547005380 - Craniectomy Template Kit: 2020-03-24 The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Torque Driver.
• 00855547005397 - Connector Cover Kit: 2020-03-24 The Connector Cover package contains 1 Connector Cover, 2 Connector Plugs, 1 Lead Strain Relief and 1 Torque Driver.
• 00855547005298 - NeuroPace® Depth Lead Kit: 2020-03-23 The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge and 1 Tunneling Tool Straw
• 00855547005304 - NeuroPace® Cortical Strip Lead Kit: 2020-03-23 The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Suture Sleeves and 1 Tunneling Tool S