Catalog Number

C-HHR-7X10

Brand Name

Biodesign Additae

Version/Model Number

G59287

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

K171817,K171817

Product Code

FTM

Product Code Name

Mesh, surgical

Public Device Record Key

68c25540-b8a1-4fc8-a57f-9f38c1bcd15f

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

November 16, 2021

Package DI Number

10827002592879

Quantity per Package

1

Contains DI Package

00827002592872

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Each