Catalog Number

-

Brand Name

BENCO

Version/Model Number

3470-479

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

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Public Device Record Key

251d04df-c954-4295-a5df-0d4dd5a6665e

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

10366975003369

Quantity per Package

18

Contains DI Package

00366975003362

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE