XactStrip 027682

GUDID 00814901020391

XactStrip, 4 Contact, Platinum, 1x4, 5mm Spacing

BLACKROCK MICROSYSTEMS, LLC

Cortical electrode

• Primary Device ID: 00814901020391
• NIH Device Record Key: f2d9b087-10b3-4e3d-be55-84d4713f5895
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XactStrip
• Version Model Number: 027682
• Catalog Number: 027682
• 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	00814901020391 [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