Catalog Number

USH-3058

Brand Name

Biopor®

Version/Model Number

USH-3058

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

KKY

Product Code Name

Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Public Device Record Key

f51244a6-9c18-4654-9291-2d4d5b6028fe

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-