Catalog Number

ECL4142

Brand Name

Medline Industries, Inc.

Version/Model Number

ECL4142

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PUI

Product Code Name

Drape, surgical, exempt

Public Device Record Key

1b10c55a-fe45-498b-9fd5-4af296a73948

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

August 30, 2021

Package DI Number

40193489848596

Quantity per Package

20

Contains DI Package

10193489848595

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE