Catalog Number

-

Brand Name

STRADIS HEALTHCARE

Version/Model Number

ZZ-0956

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

LRO

Product Code Name

General Surgery Tray

Public Device Record Key

8aba036c-86a8-44cf-bff1-54f20f3f0517

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

April 27, 2022

Package DI Number

M752ZZ09561

Quantity per Package

10

Contains DI Package

M752ZZ09560

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE