Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

033-LBLUE

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

7a5b96e0-5808-4565-9b3c-b29cfda25f79

Public Version Date

January 16, 2020

Public Version Number

1

DI Record Publish Date

January 08, 2020

Package DI Number

D838033LBLUE8

Quantity per Package

5

Contains DI Package

D838033LBLUE6

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE