Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

SR-1000

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"

-

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

MCZ

Product Code Name

Suture Removal Kit

Public Device Record Key

ad16008e-3237-42cb-b608-45fea1df8d15

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 12, 2017

Package DI Number

M752SR10005

Quantity per Package

50

Contains DI Package

M752SR10000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box