ALARA Neuro Access Needle Kit

FDA UDI

Class II (US FDA UDI)

by Surgentec Llc

Identity

Trade Name: ALARA Neuro Access Needle Kit FDA UDI
Generic Name: Nerve-locating system probe, single-use FDA UDI
Device Name: ALARA Neuro Access Needle Two Pack - Diamond Tip FDA UDI
Model / Reference: AAN-09-2NSW FDA UDI
Description: ALARA Neuro Access Needle Two Pack - Diamond Tip FDA UDI

Identifiers

Primary DI / UDI-DI: 00858406007396 FDA UDI
510(k) Number: K190163 FDA UDI
FDA Product Code: PDQ FDA UDI
GMDN Term: Nerve-locating system probe, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.1820 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: Nerve-locating system probe, single-use

ALARA Neuro Access Needle Kit by Surgentec Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: Surgentec Llc

Sources (1)

FDA UDI 9ae9c63f-511e-4ad0-8a69-a389cf25f6a1 34 fields · synced May 30, 2026