Catalog Number

-

Brand Name

Duraseal

Version/Model Number

20-2050

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

-

Product Code

NQR

Product Code Name

Sealant, dural

Public Device Record Key

69eeeba6-a334-4c35-9e7a-fe380fcf099b

Public Version Date

August 10, 2022

Public Version Number

4

DI Record Publish Date

September 22, 2014

Package DI Number

10884521056435

Quantity per Package

5

Contains DI Package

20884521056432

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE