Catalog Number

400005B

Brand Name

Equipment Cover

Version/Model Number

400005B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2018

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MMP

Product Code Name

Cover, Barrier, Protective

Public Device Record Key

f698683a-2044-47ac-98e9-059f2f6c0d62

Public Version Date

December 31, 2018

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

20886333212846

Quantity per Package

20

Contains DI Package

00886333212842

Package Discontinue Date

December 31, 2018

Package Status

Not in Commercial Distribution

Package Type

Box