Catalog Number

B-2112

Brand Name

Opaquer

Version/Model Number

B-2112

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

-

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

K874557,K874557

Product Code

EBC

Product Code Name

SEALANT, PIT AND FISSURE, AND CONDITIONER

Public Device Record Key

5a533c9a-7e38-47c3-aa17-4364b73c80ab

Public Version Date

October 19, 2022

Public Version Number

1

DI Record Publish Date

October 11, 2022

Package DI Number

10810111542415

Quantity per Package

1

Contains DI Package

00810111542418

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Item No: B-2112Q