Catalog Number

-

Brand Name

Meso Bilayer Surgical Mesh

Version/Model Number

30060-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 15, 2015

Issuing Agency

In HIBCC

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

K132025

Product Code

FTM

Product Code Name

Mesh, Surgical

Public Device Record Key

9cb1d270-995d-4b23-b07e-c4ba9ffe6bb2

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

September 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-