Catalog Number

C-SLH-8H-20X30

Brand Name

Biodesign

Version/Model Number

G48216

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K133306

Product Code

OXK

Product Code Name

Mesh, surgical, collagen, large abdominal wall defects

Public Device Record Key

4f69b5e5-5af9-41d8-9234-df69ca118514

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

November 03, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-