Catalog Number

-

Brand Name

STRADIS

Version/Model Number

816-454N

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 12, 2022

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

-

Product Code

NAB

Product Code Name

Gauze/Sponge,Nonresorbable For External Use

Public Device Record Key

22b0171f-32a0-4a73-9649-0f32952f0179

Public Version Date

May 13, 2022

Public Version Number

3

DI Record Publish Date

February 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-