Catalog Number

EVCOVER

Brand Name

Instrument Cover with PullUp Insert

Version/Model Number

1036

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

c59d6f38-668c-4656-8bb8-e73a2cb3c020

Public Version Date

May 26, 2021

Public Version Number

3

DI Record Publish Date

March 13, 2020

Package DI Number

10841912106254

Quantity per Package

25

Contains DI Package

00841912106257

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-