Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

N401

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

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

-

Product Code

EHY

Product Code Name

Tray, Impression, Preformed

Public Device Record Key

30e86c22-7852-4bdd-8ff4-f8eb31cc7eaa

Public Version Date

January 08, 2020

Public Version Number

1

DI Record Publish Date

December 31, 2019

Package DI Number

D838N4018

Quantity per Package

2

Contains DI Package

D838N4016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE