Catalog Number

EBSI1551

Brand Name

MEDLINE

Version/Model Number

EBSI1551

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

ecc7f5da-2633-4ccc-a8e5-27a1d01c1b58

Public Version Date

October 25, 2022

Public Version Number

1

DI Record Publish Date

October 17, 2022

Package DI Number

00653160355932

Quantity per Package

20

Contains DI Package

10653160355939

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE