Catalog Number

EBSI1115

Brand Name

MEDLINE

Version/Model Number

EBSI1115

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

OXQ

Product Code Name

Dressing change tray

Public Device Record Key

5aabf554-11b5-4616-ac18-63580873c43d

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

January 01, 2022

Package DI Number

40889942748243

Quantity per Package

20

Contains DI Package

10889942748242

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE