Catalog Number

-

Brand Name

STRADIS HEALTHCARE

Version/Model Number

KPX3429

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

a70038a7-b3f9-4efe-aa61-17baaf951d34

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

March 21, 2022

Package DI Number

M752KPX34291

Quantity per Package

25

Contains DI Package

M752KPX34290

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE