GUDID 00887517161390

NV ET Tube, 8mm EMG ID

Nuvasive, Inc.

Neurophysiologic monitoring system

• Primary Device ID: 00887517161390
• NIH Device Record Key: 6d4fed19-d214-4bf9-86d6-4c1f1735c805
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2010380
• 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
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517161390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133530

FDA Product Code

• PDQ: Neurosurgical nerve locator

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

Devices Manufactured by Nuvasive, Inc.

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• 00195377161307 - ReLine: 2024-05-29 RELINE Reducer, Politician
• 00195377161314 - ReLine: 2024-05-29 RELINE Lock Screw Starter, Politician
• 00195377055521 - Nimbus: 2024-05-01 Maxcess Adapter, A-Arm Threaded
• 00195377055538 - Nimbus: 2024-05-01 Nimbus Adapter, Large Clamp
• 00195377055545 - Nimbus: 2024-05-01 Nimbus Adapter, Medium Clamp
• 00195377055552 - Nimbus: 2024-05-01 Nimbus Adapter, Small Clamp
• 00195377061232 - Nimbus: 2024-05-01 Nimbus Adapters Tray