Catalog Number

1011

Brand Name

System Cover Kit

Version/Model Number

1011

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

K970885,K970885

Product Code

MMP

Product Code Name

Cover, Barrier, Protective

Public Device Record Key

3a28a6e9-1263-416e-bfa4-95b58fb30973

Public Version Date

May 18, 2021

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

10841912100559

Quantity per Package

24

Contains DI Package

00841912100552

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-