Catalog Number

-

Brand Name

ProCol Vascular Bioprosthesis

Version/Model Number

HJL016-10-N

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"

-

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

LXA

Product Code Name

Tissue Graft Of 6mm And Greater

Public Device Record Key

8ab140bd-427b-4ffc-adad-af1981befcc4

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

August 14, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-