Catalog Number

8003

Brand Name

PreveLeak™ 10 pack Tips

Version/Model Number

10 pack Tips

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

NBE

Product Code Name

Sealant,Polymerizing

Public Device Record Key

002bd2fb-d421-4ac2-8f31-df32a25f9c63

Public Version Date

February 21, 2022

Public Version Number

3

DI Record Publish Date

December 31, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-