Catalog Number

STR-022780-00

Brand Name

NeuroProbe

Version/Model Number

Shielded

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K120098,K120098

Product Code

GZL

Product Code Name

Electrode, Depth

Public Device Record Key

cedac085-3440-4b7e-afc1-9ca385ee9f69

Public Version Date

November 22, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

17290014954356

Quantity per Package

10

Contains DI Package

07290014954359

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton