Catalog Number

-

Brand Name

BENCO

Version/Model Number

4549-419

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

MUH

Product Code Name

System,X-Ray,Extraoral Source,Digital

Public Device Record Key

efb98fc1-2dcd-445f-ad8b-855e9c4d0f32

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 14, 2016

Package DI Number

10366975002553

Quantity per Package

100

Contains DI Package

00366975002556

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE