Catalog Number

3530

Brand Name

UltraSeal XT

Version/Model Number

3530

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 05, 2018

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

K112517

Product Code

EBC

Product Code Name

SEALANT, PIT AND FISSURE, AND CONDITIONER

Public Device Record Key

54270f6a-25c2-4e4d-a631-c33359931e1c

Public Version Date

September 05, 2018

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-