Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

1140-WHITE

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

f1604112-29bb-4b27-bb29-7b84af282dfe

Public Version Date

January 15, 2020

Public Version Number

1

DI Record Publish Date

January 07, 2020

Package DI Number

D8381140WHITE8

Quantity per Package

20

Contains DI Package

D8381140WHITE2

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE