Catalog Number

-

Brand Name

NeuroShield

Version/Model Number

NS3020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K190246,K190246

Product Code

JXI

Product Code Name

Cuff, Nerve

Public Device Record Key

919ef7ab-b93a-416d-b859-56da9f553c81

Public Version Date

September 14, 2022

Public Version Number

1

DI Record Publish Date

September 06, 2022

Package DI Number

07640181711208

Quantity per Package

20

Contains DI Package

07640181711017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping carton