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Nvm5

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
NVM5 FDA UDI
Generic Name
Neurophysiologic monitoring system FDA UDI
Device Name
NVM5 Control Unit- 3 FDA UDI
Model / Reference
2023000 FDA UDI
Description
NVM5 Control Unit- 3 FDA UDI

Identifiers

Primary DI / UDI-DI
00887517957368 FDA UDI
510(k) Number
K162313 FDA UDI
FDA Product Code
PDQ FDA UDI
IKN FDA UDI
OLO FDA UDI
GWF FDA UDI
ETN FDA UDI
HAW FDA UDI
GMDN Term
Neurophysiologic monitoring system FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Neurophysiologic monitoring system

Nvm5 by Nuvasive, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neurophysiologic monitoring system.

Cleared under the same submission

K162313 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nuvasive, Inc.

Sources (1)

  • FDA UDI ce37ed28-3852-47ab-b67a-40d5fddb2b2d 35 fields · synced May 31, 2026