Catalog Number

-

Brand Name

ALARA Neuro Access Needle Kit

Version/Model Number

AAN-09-2NSW

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190163

Product Code

PDQ

Product Code Name

Neurosurgical Nerve Locator

Public Device Record Key

9ae9c63f-511e-4ad0-8a69-a389cf25f6a1

Public Version Date

September 20, 2021

Public Version Number

2

DI Record Publish Date

November 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-