PULSE

Basic Information

• Brand Name: PULSE
• Primary DI: 00887517818997
• Version / Model: 1840160
• Company Name: Nuvasive, Inc.
• Labeler DUNS: 053950783
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-26
• Public Version: 1
• Public Version Date: 2018-07-27
• Public Version Status: New
• Public Device Record Key: 385a54bd-18ba-4456-9fc5-e70b2b99bc2c

Device Description

PULSE Needle EMG Electrodes

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HAW	Neurological stereotaxic Instrument	Neurology	882.4560	2
ETN	STIMULATOR, NERVE	Ear, Nose, Throat	874.1820	2
PDQ	Neurosurgical nerve locator	Ear, Nose, Throat	874.1820	2
GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE	Neurology	882.1870	2
IKN	Electromyograph, diagnostic	Physical Medicine	890.1375	2
OLO	Orthopedic stereotaxic instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11441	Electromyographic needle electrode, single-use	A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887517818997	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K162313	000