PULSE

GUDID 00195377060730

Pulse Nav Instrument Mesh Set 1

Nuvasive, Inc.

Orthopaedic stereotactic surgery system

• Primary Device ID: 00195377060730
• NIH Device Record Key: 3087fb0f-387f-4d3b-9969-e570595a1ae4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PULSE
• Version Model Number: PULSENAVINSM1
• 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
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• 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	00195377060730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143579

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

[00195377060730]

Moist Heat or Steam Sterilization

[00195377060730]

Moist Heat or Steam Sterilization

[00195377060730]

Moist Heat or Steam Sterilization

[00195377060730]

Moist Heat or Steam Sterilization

[00195377060730]

Moist Heat or Steam Sterilization

[00195377060730]

Moist Heat or Steam Sterilization

[00195377060730]

Moist Heat or Steam Sterilization

[00195377060730]

Moist Heat or Steam Sterilization

[00195377060730]

Moist Heat or Steam Sterilization

[00195377060730]

Moist Heat or Steam Sterilization

[00195377060730]

Moist Heat or Steam Sterilization

[00195377060730]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-16
• Device Publish Date: 2022-05-06

On-Brand Devices [PULSE]

• 00887517984814: Pulse II Touchsceen Monitor
• 00887517975065: PULSE II System
• 00887517973900: Pulse Pointer, Straight Small
• 00887517973887: Pulse Spine Clamp, Large
• 00887517973870: Pulse Spine Clamp, Medium
• 00887517973863: Pulse Spine Clamp, Small
• 00887517973801: PULSE Posterior Confirmation Fixture
• 00887517973160: PULSE Patient Reference Array Kit
• 00887517972309: Pulse Camera Cart
• 00887517953469: PULSE Camera
• 00887517988065: PULSE II Flat Array, A
• 00887517988058: PULSE II Flat Array, B
• 00887517988041: PULSE II Flat Array, C
• 00887517973894: Pulse Driver, Pin
• 00887517814128: PULSE Cart Power and Data Cable
• 00887517996138: PULSE Adapter, VGA to DVI
• 00887517996121: PULSE Adapter, BNC to DVI
• 00887517990808: PULSE Patient Module 4
• 00887517990792: PULSE III System
• 00887517986528: PULSE II Cable, Ethernet
• 00887517939807: PULSE SSEP Pod
• 00887517011541: Pulse System
• 00887517011534: Pulse IOM Set
• 00887517001627: PULSE Cable, BNC
• 00887517990785: PULSE Navigation Instrument Set, BETA
• 00887517990778: PULSE II System, BETA
• 00887517990761: PULSE Camera Cart, BETA
• 00887517990754: PULSE Camera Set, BETA
• 00887517955319: PULSE Control Unit DVI Adapter
• 00887517945822: PULSE Monitor Cable, Shippable
• 00887517945815: PULSE CPU Power Cable, Shippable
• 00887517931771: PULSE Control Unit, Shippable
• 00887517834157: PULSE Patient Module 4
• 00887517994141: PULSE Flat Array C, Beta
• 00887517994134: PULSE Flat Array B, Beta
• 00887517994127: PULSE Flat Array A, Beta
• 00887517991911: PULSE TMAP Kit
• 00887517960344: Pulse Shippable Monitor Set - ALPHA
• 00887517960337: Pulse Shippable Control Unit Set - ALPHA
• 00887517960320: Pulse Shippable Cart Set - ALPHA
• 00887517939876: MIOM Electrode Kit, Surface
• 00887517939869: MIOM Electrode Kit, Needle
• 00887517939852: PULSE MEP Surface Electrodes, 2 Pack
• 00887517939845: PULSE MEP Needle Electrodes, 2 Pack
• 00887517939838: PULSE SSEP Surface Electrodes
• 00887517939821: PULSE SSEP Needle Electrodes
• 00887517824578: Multimodality Harness
• 00887517824554: EMG Electrode Kit, Surface
• 00887517824530: EMG Electrode Kit, Needle
• 00887517824523: Stimulation Clip-Activator, Single