Uroval

GUDID 00852523007024

6' Electrode Lead Wire Set for use with the Uroval BRS System.

UROVAL, INC.

Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead

• Primary Device ID: 00852523007024
• NIH Device Record Key: 2a70180b-8083-4871-9c06-0425e10547fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uroval
• Version Model Number: BR5338 - Electrode Lead Wire Set
• Company DUNS: 069555565
• Company Name: UROVAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Length: 6 Feet
• Length: 6 Feet
• Length: 6 Feet
• Length: 6 Feet
• Length: 6 Feet
• Length: 6 Feet
• Length: 6 Feet
• Length: 6 Feet
• Length: 6 Feet
• Length: 6 Feet
• Length: 6 Feet
• Length: 6 Feet
• Length: 6 Feet
• Length: 6 Feet
• Length: 6 Feet
• Length: 6 Feet
• Length: 6 Feet

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852523007024 [Primary]

FDA Product Code

• IKN: Electromyograph, Diagnostic

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: 2018-10-29
• Device Publish Date: 2018-09-27

On-Brand Devices [Uroval]

• 00852523007062: The Uroval BRS System is used to record and display electromyogram (EMG )signals. In addition,
• 00852523007024: 6' Electrode Lead Wire Set for use with the Uroval BRS System.