Catalog Number

LRM0615

Brand Name

Gentrix®

Version/Model Number

LRM0615

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2020

Issuing Agency

In GS1

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

K040621

Product Code

FTM

Product Code Name

Mesh, surgical

Public Device Record Key

3e3bc5f6-514d-441b-a45c-67c2a4e6e9c3

Public Version Date

June 10, 2022

Public Version Number

8

DI Record Publish Date

January 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-