Catalog Number

-

Brand Name

Neuron

Version/Model Number

PND6F10512

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"

Yes

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

K082290

Product Code

DQY

Product Code Name

CATHETER, PERCUTANEOUS

Public Device Record Key

e252172b-02a3-4a15-b2b4-fdf8b2bd7be6

Public Version Date

December 22, 2021

Public Version Number

7

DI Record Publish Date

July 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-