Catalog Number

-

Brand Name

Mepilex® Border EM

Version/Model Number

281100

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

-

Product Code

NAC

Product Code Name

Dressing, wound, hydrophilic

Public Device Record Key

cada5a08-1179-4344-a1d9-c17c78d26795

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Package DI Number

07323190246656

Quantity per Package

13

Contains DI Package

07323190246663

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE