Cobra

GUDID B006LTE7003PS1

NEUROVISION MEDICAL PRODUCTS, INC.

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• Primary Device ID: B006LTE7003PS1
• NIH Device Record Key: 3b4d9293-f1f4-4b91-bd22-9883cfcd7bf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cobra
• Version Model Number: N/A
• Company DUNS: 182057401
• Company Name: NEUROVISION MEDICAL PRODUCTS, INC.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B006LTE7003PS1 [Unit of Use]
HIBCC	B006LTE7003PS52 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110989

FDA Product Code

• GWF: Stimulator, Electrical, Evoked Response

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-20
• Device Publish Date: 2020-08-12

On-Brand Devices [Cobra]

• B006LTE7003PST1: N/A
• B006LTE7003PS1: N/A
• B006LTE7003PMT1: N/A
• B006LTE7003PM1: N/A
• B006LTE7003PLT1: N/A
• B006LTE7003PL1: N/A