Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

DC-17686TM

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

e1f777ae-f2ef-42ad-bdce-16d0864c47d6

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

May 22, 2018

Package DI Number

M752DC17686TM5

Quantity per Package

20

Contains DI Package

M752DC17686TM0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box