Catalog Number

ADS201807

Brand Name

PREVELEAK SURGICAL SEALANT

Version/Model Number

ADS201807

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

P100030,P100030,P100030

Product Code

NBE

Product Code Name

Sealant, polymerizing

Public Device Record Key

8820c7f1-ae6a-42f5-9e26-49583a94a3d1

Public Version Date

March 02, 2022

Public Version Number

1

DI Record Publish Date

February 22, 2022

Package DI Number

25413765583524

Quantity per Package

10

Contains DI Package

05413765583520

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK