Catalog Number

-

Brand Name

V.A.C.®

Version/Model Number

M8275080/5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K022011

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Public Device Record Key

8cc1e05c-cfb5-4b0b-a08d-814f055c46ee

Public Version Date

September 09, 2020

Public Version Number

5

DI Record Publish Date

November 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-