Catalog Number

1696

Brand Name

Sterile Protective Barrier Kit

Version/Model Number

1696

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"

-

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

05334521-6920-45a3-beb2-35ffcd80dcf3

Public Version Date

June 09, 2020

Public Version Number

1

DI Record Publish Date

June 01, 2020

Package DI Number

10841912106520

Quantity per Package

24

Contains DI Package

00841912106523

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-