Catalog Number

BGAT-SY

Brand Name

BioGlue Surgical Adhesive

Version/Model Number

BGAT-SY

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

P010003,P010003,P010003,P010003,P010003,P010003,P010003,P010003,P010003,P010003

Product Code

MUQ

Product Code Name

Glue,Surgical,Arteries

Public Device Record Key

fb999d60-448e-4619-a726-8cd00a353730

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 12, 2016

Package DI Number

10877234000154

Quantity per Package

10

Contains DI Package

00877234000157

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box