Catalog Number

-

Brand Name

Hemaseal & Cide - Unidose

Version/Model Number

180

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

K990779,K990779,K990779

Product Code

LBH

Product Code Name

Varnish, Cavity

Public Device Record Key

9cddb7c4-837d-42ed-91d0-9a3bb9fe49ff

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

10859787002045

Quantity per Package

12

Contains DI Package

00859787002048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case