Catalog Number

-

Brand Name

Mepitel®

Version/Model Number

290799

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

K161797,K161797,K161797

Product Code

OMP

Product Code Name

negative pressure wound therapy Powered suction pump

Public Device Record Key

83004774-e44e-4616-b47b-ee1f2decef06

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Package DI Number

07332551585150

Quantity per Package

4

Contains DI Package

07332551585167

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE