Catalog Number

-

Brand Name

Invia Abdominal Dressing Kit

Version/Model Number

087.6250

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182191,K182191

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Public Device Record Key

b971720c-3e54-451a-87f3-3de0aff57922

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 13, 2019

Package DI Number

07612367054010

Quantity per Package

5

Contains DI Package

07612367054003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-