NeuroPace® Lead Accessory Kit

GUDID 00855547005229

The NeuroPace® Lead Accessory package contains 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge, 1 Tunneling Tool, 1 Tunneling Tool Tip and 1 Tunneling Tool Straw.

Neuropace, Inc.

Brain-responsive electrical stimulation system

• Primary Device ID: 00855547005229
• NIH Device Record Key: 17cf321c-8e64-4b54-bc44-b935696672f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroPace® Lead Accessory Kit
• Version Model Number: LA-02-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: true
• Serial Number: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855547005229 [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: 2014-09-24

Devices Manufactured by Neuropace, Inc.

• 00855547005434 - NeuroPace® Remote Monitor Kit: 2023-11-22 The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, and 1 Carrying Case.
• 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