PULSE

Basic Information

• Brand Name: PULSE
• Primary DI: 00195377051011
• Version / Model: 5050402
• Company Name: Nuvasive, Inc.
• Labeler DUNS: 053950783
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-06
• Public Version: 1
• Public Version Date: 2022-05-16
• Public Version Status: New
• Public Device Record Key: 6c51bcd2-4c43-4fef-8bd1-133d173a2f62

Device Description

PULSE Dual Patient Reference Array Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ETN	STIMULATOR, NERVE	Ear, Nose, Throat	874.1820	2
IKN	Electromyograph, diagnostic	Physical Medicine	890.1375	2
OWB	Interventional fluoroscopic x-ray system	Radiology	892.1650	2
OLO	Orthopedic stereotaxic instrument	Neurology	882.4560	2
HAW	Neurological stereotaxic Instrument	Neurology	882.4560	2
PDQ	Neurosurgical nerve locator	Ear, Nose, Throat	874.1820	2
JAA	System, x-ray, fluoroscopic, image-intensified	Radiology	892.1650	2
LLZ	System, image processing, radiological	Radiology	892.2050	2
GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE	Neurology	882.1870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45200	Orthopaedic stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195377051011	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K210574	000