Catalog Number

-

Brand Name

BENCO

Version/Model Number

3469-909

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)

-

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

109643c3-4e3b-4a2c-95cc-41ae7d55a304

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 16, 2016

Package DI Number

10366975003390

Quantity per Package

10

Contains DI Package

00366975003393

Package Discontinue Date

-

Package Status

-

Package Type

CASE