Catalog Number

-

Brand Name

BENCO

Version/Model Number

5216-302

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

-

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

EAT

Product Code Name

Tester, Pulp

Public Device Record Key

622031cb-6df9-4858-9c52-bd9f52c20f76

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 13, 2017

Package DI Number

10366975010824

Quantity per Package

12

Contains DI Package

00366975010827

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE