Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

HHSBRF-661

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

OXQ

Product Code Name

Dressing Change Tray

Public Device Record Key

059b2b5f-31f5-4171-9d39-64059936f675

Public Version Date

October 02, 2020

Public Version Number

1

DI Record Publish Date

September 24, 2020

Package DI Number

M752HHSBRF6615

Quantity per Package

30

Contains DI Package

M752HHSBRF6610

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OUTER BOX