Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

525-204

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

KDT

Product Code Name

Container, Specimen Mailer And Storage, Sterile

Public Device Record Key

663268b2-8876-40e1-b21c-896d6633b7f9

Public Version Date

May 25, 2022

Public Version Number

1

DI Record Publish Date

May 17, 2022

Package DI Number

M7525252041

Quantity per Package

25

Contains DI Package

M7525252040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE