Catalog Number

-

Brand Name

STRADIS HEALTHCARE

Version/Model Number

KPX4725R1

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

65b0346a-b927-412e-8b06-8c0bcd3ecb11

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

April 25, 2022

Package DI Number

M752KPX4725R11

Quantity per Package

5

Contains DI Package

M752KPX4725R10

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE