Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

N050FGW

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

-

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

MDM

Product Code Name

Instrument, Manual, Surgical, General Use

Public Device Record Key

3db84420-537f-41bb-b3d5-36a43a5db25f

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

January 08, 2020

Package DI Number

D838N050FGW8

Quantity per Package

100

Contains DI Package

D838N050FGW2

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE