Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

ZZ-0958

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MCZ

Product Code Name

Suture Removal Kit

Public Device Record Key

9de5c8e8-7255-4ca0-9a2a-3f1b2ce35a22

Public Version Date

August 04, 2021

Public Version Number

1

DI Record Publish Date

July 27, 2021

Package DI Number

M752ZZ09585

Quantity per Package

20

Contains DI Package

M752ZZ09580

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box