Catalog Number

-

Brand Name

STRADIS HEALTHCARE

Version/Model Number

813-656N

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"

Yes

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

7023ecd4-48e7-4716-af43-5156893f24f3

Public Version Date

May 09, 2022

Public Version Number

1

DI Record Publish Date

April 29, 2022

Package DI Number

M752813656N1

Quantity per Package

30

Contains DI Package

M752813656N0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-