Wand

GUDID 00855547005113

The Wand package contains 1 Wand.

Neuropace, Inc.

Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system

• Primary Device ID: 00855547005113
• NIH Device Record Key: 4348ca0a-4f3b-4b4f-900f-29f85b100fec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wand
• Version Model Number: W-02
• 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
• 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 0 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855547005113 [Primary]
GS1	00855547005236 [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: 4
• Public Version Date: 2019-08-02
• 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