Catalog Number

43210

Brand Name

STERRAD

Version/Model Number

43210

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

Yes

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

FRC

Product Code Name

Indicator, biological sterilization process

Public Device Record Key

6a1ec717-e80d-4498-bf4b-a00a4cb00b6f

Public Version Date

December 11, 2020

Public Version Number

3

DI Record Publish Date

October 10, 2017

Package DI Number

20705037048905

Quantity per Package

4

Contains DI Package

10705037048908

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case