Catalog Number

-

Brand Name

STRADIS

Version/Model Number

816-454N R1

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

51f4a693-1640-4931-bb51-bc8032f3eeed

Public Version Date

May 20, 2022

Public Version Number

1

DI Record Publish Date

May 12, 2022

Package DI Number

M752816454NR11

Quantity per Package

30

Contains DI Package

M752816454NR10

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case