Craniectomy Template Kit

GUDID 00855547005380

The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Torque Driver.

Neuropace, Inc.

Brain-responsive electrical stimulation system

• Primary Device ID: 00855547005380
• NIH Device Record Key: 2c422a2a-6ebb-4f6a-b39c-26daa2bd5dc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Craniectomy Template Kit
• Version Model Number: CT-01-K
• Company DUNS: 123369238
• Company Name: Neuropace, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855547005380 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-24
• Device Publish Date: 2020-03-16

On-Brand Devices [Craniectomy Template Kit]

• 00855547005168: The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Tor
• 00855547005380: The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Tor