Catalog Number

-

Brand Name

OsseoSeal

Version/Model Number

OS3040

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

K200623

Product Code

NPL

Product Code Name

Barrier, Animal Source, Intraoral

Public Device Record Key

d13bc19c-94cc-4dea-87b9-385febe769c6

Public Version Date

March 16, 2022

Public Version Number

1

DI Record Publish Date

March 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-