Guidance

GUDID 00887517170699

9"Laser Reticle

Nuvasive, Inc.

Neurophysiologic monitoring system

• Primary Device ID: 00887517170699
• NIH Device Record Key: b0a5913e-1613-42b6-8df7-20ad15357d31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guidance
• Version Model Number: 2039909
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00887517170699 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143641

FDA Product Code

• HAW: Neurological stereotaxic Instrument

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

On-Brand Devices [Guidance]

• 00887517172501: 12"Laser Reticle
• 00887517170699: 9"Laser Reticle
• 00887517170675: NVM5 Guidance Clip, Integrated
• 00887517170644: NVM5 Guidance Reticle Wire
• 00887517170637: NVM5 Guidance Clip, Universal
• 00887517170620: NVM5 Guidance Clip