Catalog Number

C-SLRA-45

Brand Name

Biodesign

Version/Model Number

G58397

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

K201000,K201000

Product Code

FTM

Product Code Name

Mesh, surgical

Public Device Record Key

18b66aee-03fa-4819-99de-8f1c2fb90798

Public Version Date

August 07, 2020

Public Version Number

1

DI Record Publish Date

July 30, 2020

Package DI Number

10827002583976

Quantity per Package

4

Contains DI Package

00827002583979

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX