Pulse

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name: PULSE FDA UDI
Generic Name: Neurophysiologic monitoring system FDA UDI
Device Name: PULSE SSEP Surface Electrodes FDA UDI
Model / Reference: 1840161 FDA UDI
Description: PULSE SSEP Surface Electrodes FDA UDI

Identifiers

Primary DI / UDI-DI: 00887517939838 FDA UDI
510(k) Number: K162313 FDA UDI
FDA Product Code: PDQ FDA UDI
OLO FDA UDI
IKN FDA UDI
HAW FDA UDI
GWF FDA UDI
ETN FDA UDI
GMDN Term: Neurophysiologic monitoring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.1820 FDA UDI
882.4560 FDA UDI
890.1375 FDA UDI
882.1870 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Neurophysiologic monitoring system

Pulse by Nuvasive, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K162313 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Nuvasive, Inc.

Sources (1)

FDA UDI 1957d97e-a67f-4666-8497-aee1974ec343 35 fields · synced Jun 8, 2026