Catalog Number

-

Brand Name

TSI

Version/Model Number

ML-0444S

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140088

Product Code

PDQ

Product Code Name

Neurosurgical Nerve Locator

Public Device Record Key

e11f2bf9-20da-41d8-9a5c-12619b00e91b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-