Guidance

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name: Guidance FDA UDI
Generic Name: Neurophysiologic monitoring system FDA UDI
Device Name: 12"Laser Reticle FDA UDI
Model / Reference: 2039912 FDA UDI
Description: 12"Laser Reticle FDA UDI

Identifiers

Primary DI / UDI-DI: 00887517172501 FDA UDI
510(k) Number: K143641 FDA UDI
FDA Product Code: HAW FDA UDI
IKN FDA UDI
OLO FDA UDI
ETN FDA UDI
PDQ FDA UDI
GWF FDA UDI
GMDN Term: Neurophysiologic monitoring system FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Neurophysiologic monitoring system

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

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Cleared under the same submission

K143641 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 a002c52c-5245-4f2a-bfcd-adf1420d0458 35 fields · synced May 31, 2026