Catalog Number

STR-222291-00

Brand Name

NeuroProbe

Version/Model Number

Non-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)

-

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

67d2506d-847b-4e81-872b-5179d2a7437b

Public Version Date

November 22, 2019

Public Version Number

5

DI Record Publish Date

October 16, 2017

Package DI Number

17290014954073

Quantity per Package

10

Contains DI Package

07290014954076

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton