Catalog Number

66077842

Brand Name

Gluma

Version/Model Number

66077842

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K093575

Product Code

LBH

Product Code Name

VARNISH, CAVITY

Public Device Record Key

06e909af-2f73-46e9-be64-56faf18c5ff0

Public Version Date

April 18, 2019

Public Version Number

1

DI Record Publish Date

April 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-