Retropsoas Electrode

GUDID 00810135960519

Retropsoas Electrode, NERVE CUFF ELECTRODE, 6MM The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Nerve-locating system probe, single-use

• Primary Device ID: 00810135960519
• NIH Device Record Key: e0db9e56-168a-451d-95fd-3e30e4ca4c72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Retropsoas Electrode
• Version Model Number: ELEC1000-06
• Company DUNS: 047486041
• Company Name: NVISION BIOMEDICAL TECHNOLOGIES, 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: 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: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com

Device Dimensions

• Lumen/Inner Diameter: 6 Millimeter
• Height: 5 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Height: 5 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Height: 5 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Height: 5 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Height: 5 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Height: 5 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Height: 5 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Height: 5 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Height: 5 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Height: 5 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Height: 5 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Height: 5 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Height: 5 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Height: 5 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Height: 5 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Height: 5 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Height: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810135960519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230853

FDA Product Code

• ETN: Stimulator, Nerve

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: 2023-11-02
• Device Publish Date: 2023-10-25

On-Brand Devices [Retropsoas Electrode]

• 00810135960564: Retropsoas Electrode, NERVE CUFF TRIAL SIZER, 8/10MM. The EARP Nerve Cuff Electrode is used t
• 00810135960557: Retropsoas Electrode, NERVE CUFF TRIAL SIZER, 4/6MM. The EARP Nerve Cuff Electrode is used to
• 00810135960540: Retropsoas Electrode, NERVE CUFF APPLICATOR. The EARP Nerve Cuff Electrode is used to perform
• 00810135960533: Retropsoas Electrode, NERVE CUFF ELECTRODE, 10MM The EARP Nerve Cuff Electrode is used to per
• 00810135960526: Retropsoas Electrode, NERVE CUFF ELECTRODE, 8MM The EARP Nerve Cuff Electrode is used to perf
• 00810135960519: Retropsoas Electrode, NERVE CUFF ELECTRODE, 6MM The EARP Nerve Cuff Electrode is used to perf
• 00810135960502: Retropsoas Electrode, NERVE CUFF ELECTRODE, 4MM The EARP Nerve Cuff Electrode is used to perf