Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

SR-1010

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

LRO

Product Code Name

General Surgery Tray

Public Device Record Key

b9cf9daf-d71e-4829-bc1d-ed200e1c5372

Public Version Date

July 12, 2018

Public Version Number

1

DI Record Publish Date

June 11, 2018

Package DI Number

M752SR10105

Quantity per Package

50

Contains DI Package

M752SR10100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box