Catalog Number

SLH-4S-2X3

Brand Name

Biodesign

Version/Model Number

G13808

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2021

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

K160869,K980431

Product Code

FTM

Product Code Name

Mesh, surgical

Public Device Record Key

776c4ff8-c385-4812-bcaa-7814a6607426

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

November 03, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-