Catalog Number

MAG1-2020

Brand Name

InoMesh

Version/Model Number

MAG1-2020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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

-

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Public Device Record Key

7b516c3c-f8e9-4a84-a5ce-28bb55a3c1e8

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

December 28, 2015

Package DI Number

MDLXMAG120203

Quantity per Package

12

Contains DI Package

MDLXMAG120200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-