Catalog Number

366-000080-00

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

K052527,K052527

Product Code

GZL

Product Code Name

Electrode, Depth

Public Device Record Key

6974b937-6159-49a9-a328-713c72b6b513

Public Version Date

November 22, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

17290016450313

Quantity per Package

10

Contains DI Package

07290016450316

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton