Catalog Number

-

Brand Name

Mepilex® Ag

Version/Model Number

287400

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

K071354,K071354,K071354

Product Code

FRO

Product Code Name

Dressing, wound, drug

Public Device Record Key

1f80e3fe-5eef-4db8-9d73-07c2ea887e58

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Package DI Number

07332430612151

Quantity per Package

4

Contains DI Package

07332430612168

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE