Catalog Number

BBF0008DU

Brand Name

Biofiber™

Version/Model Number

BBF0008DU

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"

Yes

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

-

Product Code

FTL

Product Code Name

Mesh, surgical, polymeric

Public Device Record Key

df258209-cef6-4f0c-aae8-eb0ff3c1a545

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

October 16, 2015

Package DI Number

10846832006059

Quantity per Package

4

Contains DI Package

00846832006052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-