Catalog Number

-

Brand Name

BENCO

Version/Model Number

4692-808

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EJI

Product Code Name

Syringe, Cartridge

Public Device Record Key

5c45d8b6-a7e6-4402-81c5-aea9b678fa71

Public Version Date

November 22, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10366975002355

Quantity per Package

12

Contains DI Package

00366975002358

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box