Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

6009

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

893c622b-3310-44b4-abe1-735394bbbce8

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

February 07, 2018

Package DI Number

D83860098

Quantity per Package

10

Contains DI Package

D83860092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case