Catalog Number

-

Brand Name

TSI

Version/Model Number

ML-0342-100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 08, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PDQ

Product Code Name

Neurosurgical Nerve Locator

Public Device Record Key

a4f29f8a-f3e2-4200-b4a2-b26197166455

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

January 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-