Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

HCT1212SB

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

MCY

Product Code Name

Wound Dressing Kit

Public Device Record Key

faa4bc04-a10b-4eaf-9bcb-002e575685cd

Public Version Date

April 07, 2021

Public Version Number

1

DI Record Publish Date

March 30, 2021

Package DI Number

M752HCT1212SB5

Quantity per Package

30

Contains DI Package

M752HCT1212SB0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Box