Catalog Number

352AST

Brand Name

Metalite™

Version/Model Number

352AST

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

6bfd9705-c164-402c-bb3d-48419e9018da

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 22, 2016

Package DI Number

00634782571283

Quantity per Package

12

Contains DI Package

00634782071677

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case