Catalog Number

-

Brand Name

Stradis Healtcare

Version/Model Number

KPX4725

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 2022

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)

Yes

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

LRO

Product Code Name

General Surgery Tray

Public Device Record Key

dec0e5c4-97cc-4d5e-8520-ea380eee4c24

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

December 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-