Catalog Number

AP10100R

Brand Name

AlboSure Vascular Patch

Version/Model Number

AP10100R

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

K101740

Product Code

DXZ

Product Code Name

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Public Device Record Key

ce4fdef3-6e1f-4333-9c5b-83797c39d270

Public Version Date

April 21, 2021

Public Version Number

5

DI Record Publish Date

July 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-