Catalog Number

353Q-3MC

Brand Name

Metalite

Version/Model Number

353Q-3MC

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KYT

Product Code Name

Light, Examination, Medical, Battery Powered

Public Device Record Key

239a1f65-5d72-48a9-9000-d3330f457eb2

Public Version Date

September 03, 2018

Public Version Number

1

DI Record Publish Date

August 03, 2018

Package DI Number

00634782595418

Quantity per Package

16

Contains DI Package

00634782895419

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master