Remote Monitoring

GUDID 00887517206183

NV RM Surface Electrodes, IOM EMG Module

Nuvasive, Inc.

Neurophysiologic monitoring system

• Primary Device ID: 00887517206183
• NIH Device Record Key: a295c686-0500-42e8-aeb1-2e2294e2d514
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remote Monitoring
• Version Model Number: 8010202
• Company DUNS: 053950783
• Company Name: Nuvasive, 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: true
• 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: +1(858)909-1800
• Email: RA_UDI@nuvasive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517206183 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143641

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: 2019-11-25
• Device Publish Date: 2019-11-15

On-Brand Devices [Remote Monitoring]

• 00887517213402: Multimodality IOM Kit
• 00887517212993: RLN IOM Kit
• 00887517212986: EMG IOM Kit
• 00887517212979: MEP IOM Kit
• 00887517212962: SSEP IOM Kit
• 00887517210838: NV RM Needle Module, NVM5 IOM MEP/EMG
• 00887517210821: NV RM Needle Module, NVM5 IOM EMG
• 00887517206695: NV RM Module, NVM5 IOM SSEP
• 00887517206688: NV RM Surface Module, NVM5 IOM MEP/EMG
• 00887517206671: NV RM Surface Module, NVM5 IOM EMG
• 00887517206183: NV RM Surface Electrodes, IOM EMG Module
• 00887517206176: NV RM Needle Electrodes, IOM EMG Module