Catalog Number

99400

Brand Name

Sterrad

Version/Model Number

99400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LRP

Product Code Name

TRAY, SURGICAL

Public Device Record Key

138c597e-6596-4918-9be0-26461643eb24

Public Version Date

September 16, 2022

Public Version Number

7

DI Record Publish Date

May 31, 2018

Package DI Number

20705037043108

Quantity per Package

4

Contains DI Package

10705037043101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case