Catalog Number

-

Brand Name

SteriTec Self-Contained BI Steam Box

Version/Model Number

BI-038

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

bb29308d-9b8c-46fc-b8c4-27f96e583e62

Public Version Date

November 26, 2020

Public Version Number

1

DI Record Publish Date

November 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-