Catalog Number

C-SLH-6H-4X7

Brand Name

Biodesign

Version/Model Number

G52867

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

K034039,K161221,K034039,K161221

Product Code

FTM

Product Code Name

Mesh, surgical

Public Device Record Key

d0b2965f-d34b-4f69-8063-96ab10f0f861

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

November 03, 2015

Package DI Number

10827002528670

Quantity per Package

1

Contains DI Package

00827002528673

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-