Catalog Number

MT801.5DEX

Brand Name

Alloy Melter

Version/Model Number

MT801.5DEX

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

KPY

Product Code Name

Shield, protective, personnel

Public Device Record Key

e0781b9f-3d29-4ba8-abd0-fbf2bce7e05a

Public Version Date

March 31, 2020

Public Version Number

3

DI Record Publish Date

June 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-