XactStrip 027673

GUDID 00814901020742

XactStrip, 10 Contact, Platinum, 1x10, 10mm Spacing

BLACKROCK MICROSYSTEMS, LLC

Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode Cortical electrode

• Primary Device ID: 00814901020742
• NIH Device Record Key: d992233f-14d3-41b2-8adb-d52b4aa14d8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XactStrip
• Version Model Number: 027673
• Catalog Number: 027673
• Company DUNS: 827132015
• Company Name: BLACKROCK MICROSYSTEMS, LLC
• 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: false
• Serial Number: true
• 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: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814901020742 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191346

FDA Product Code

• GYC: Electrode, Cortical

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: 2021-02-11
• Device Publish Date: 2021-02-03

On-Brand Devices [XactStrip]

• 00814901020742: XactStrip, 10 Contact, Platinum, 1x10, 10mm Spacing
• 00814901020728: XactStrip, 8 Contact, Platinum, 1x8, 10mm Spacing
• 00814901020704: XactStrip, 6 Contact, Platinum, 1x6, 10mm Spacing
• 00814901020681: XactStrip, 4 Contact, Platinum, 1x4, 10mm Spacing
• 00814901020391: XactStrip, 4 Contact, Platinum, 1x4, 5mm Spacing
• 00814901020377: XactStrip, 10 Contact, Platinum, 1x10, 5mm Spacing
• 00814901020353: XactStrip, 8 Contact, Platinum, 1x8, 5mm Spacing
• 00814901020339: XactStrip, 6 Contact, Platinum, 1x6, 5mm Spacing
• 00814901020827: XactStrip, 10 Contact, Platinum, Reinforcement, 1x10, 10mm Spacing
• 00814901020803: XactStrip, 8 Contact, Platinum, Reinforcement, 1x8, 10mm Spacing
• 00814901020780: XactStrip, 6 Contact, Platinum, Reinforcement, 1x6, 10mm Spacing
• 00814901020766: XactStrip, 4 Contact, Platinum, Reinforcement, 1x4, 10mm Spacing
• 00814901020469: XactStrip, 10 Contact, Platinum, Reinforcement, 1x10, 5mm Spacing
• 00814901020445: XactStrip, 8 Contact, Platinum, Reinforcement, 1x8, 5mm Spacing
• 00814901020421: XactStrip, 6 Contact, Platinum, Reinforcement, 1x6, 5mm Spacing
• 00814901020407: XactStrip, 4 Contact, Platinum, Reinforcement, 1x4, 5mm Spacing