NVM5

GUDID 00887517168658

NVM5 Keyboard, Mini Trackball

Nuvasive, Inc.

Neurophysiologic monitoring system

• Primary Device ID: 00887517168658
• NIH Device Record Key: 652d13f9-ccad-41c0-bfd1-ac1aa6ba802a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NVM5
• Version Model Number: 2021005
• 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	00887517168658 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143641

FDA Product Code

• IKN: Electromyograph, diagnostic

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 [NVM5]

• 00887517462930: NVM5 Corkscrew Electrode, S.D. SSEP
• 00887517461704: NVM5 Harness, S.D. SSEP Packaged
• 00887517317698: NVM5 SSEP Cranial Array, Sterile Package
• 00887517307903: NVM5 Module, Surgeon Driven SSEP
• 00887517261540: NVM5 Electrodes, L1/L2 & Abdominal
• 00887517259295: NVM5 Activator, Sterile & Packaged
• 00887517206657: NVM5 Module, SSEP
• 00887517206640: NVM5 Harness, Next Gen Module MEP/EMG
• 00887517206633: NVM5 Module, Next Gen Module EMG
• 00887517170606: NVM5 XLIF Dilator Kit, Pkg Ster
• 00887517168696: NVM5 Clips DSP & In-Line Activator
• 00887517168665: NV M5 Patient Module II
• 00887517168658: NVM5 Keyboard, Mini Trackball
• 00887517168641: NV Next Generation Powered USB
• 00887517168634: NV Next Generation Patient Mod
• 00887517168610: NV M5 Control Unit
• 00887517168603: NVM5 Control Unit-2
• 00887517166944: NV Clips DSC & In-Line Activator
• 00887517166937: NVM5 Probe, Single Use Sterile Packaged
• 00887517159373: NVM5 Electrodes, 2-Pack Solid Gel
• 00887517159335: NVM5 Pediatric Gel Electrodes
• 00887517141095: NVM5 PM, 2+SSEPs
• 00887517135803: NVM5 SSEP Harness, Packaged
• 00887517116239: NVM5 Dual Needle Electrode, 14 Pack
• 00887517116222: NVM5 Module, Needle Electrode EMG
• 00887517111692: NVM5 Needle Electrode
• 00887517097071: NVM5 Cranial Array, SSEP
• 00887517089151: NVM5 with EMG, MEP and Guidance
• 00887517073136: NVM5 NV Dilator, 12mm Disp
• 00887517073129: NVM5 NV Dilator, 9mm Disposable
• 00887517073112: NVM5 NV Dilator, 6mm Disposable
• 00887517073105: 6, 9, 12 mm Dilators Set
• 00887517069566: NVM5 CU II, On Cart
• 00887517645708: NVM5 Dual Gel Electrodes
• 00887517145055: NVM5 Needle Elec, 1.5m Light Blue Black
• 00887517145048: NVM5 Needle Electrodes, 1.5m Gray White
• 00887517075338: NVM5 Connnector, Needle Electrodes
• 00887517163202: NVM5 Connector Adapter/Needle Electrodes
• 00887517746696: NVM5 Multimodality Kit, Needle
• 00887517746689: NVM5 Multimodality Kit, Surface
• 00887517207272: NVM5 Needle Module, SSEP
• 00887517207265: NVM5 Needle Module, MEP/EMG
• 00887517207258: NVM5 Needle Module, EMG
• 00887517073167: NVM5 Surgical Skin Marker
• 00887517163271: NVJJB Dual Electrode Imped Meter Leads
• 00887517109972: Brown/White Paired 2.5m Needle Electrode
• 00887517109965: Pink/Black Paired 2.5m Needle Electrodes
• 00887517109934: Paired Sticky Pad Stim Electrodes
• 00887517109927: Blue/White Paired Needle Electrode
• 00887517109910: White/Red Paired Needle Electrode