Uroval BRS01

GUDID 00852523007062

The Uroval BRS System is used to record and display electromyogram (EMG )signals. In addition, the BRS System will determine latency time intervals of the bulbocavernosus reflex (BCR). The Uroval BRS System also has report generation capabilities. The Uroval BRS System uses a probe, with a single use disposable tip to evoke a BCR response and activate recording and timing of EMG signals. The Uroval BRS System uses pre-gelled surface electrodes to monitor the muscle activity.

UROVAL, INC.

Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph

• Primary Device ID: 00852523007062
• NIH Device Record Key: ed7eb397-fb81-45ae-ace7-b9980684e246
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uroval
• Version Model Number: BRS System
• Catalog Number: BRS01
• Company DUNS: 069555565
• Company Name: UROVAL, 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: false
• Lot Batch: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 785-539-1787
• Email: info@uroval.com
• Phone: 785-539-1787
• Email: info@uroval.com
• Phone: 785-539-1787
• Email: info@uroval.com
• Phone: 785-539-1787
• Email: info@uroval.com
• Phone: 785-539-1787
• Email: info@uroval.com
• Phone: 785-539-1787
• Email: info@uroval.com
• Phone: 785-539-1787
• Email: info@uroval.com
• Phone: 785-539-1787
• Email: info@uroval.com
• Phone: 785-539-1787
• Email: info@uroval.com
• Phone: 785-539-1787
• Email: info@uroval.com
• Phone: 785-539-1787
• Email: info@uroval.com
• Phone: 785-539-1787
• Email: info@uroval.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852523007062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083679

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.