Catalog Number

2283013

Brand Name

Maxima Radiopaque Kit

Version/Model Number

2283013

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

Yes

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

-

FDA Premarket Submission

-

Product Code

ELM

Product Code Name

Denture, plastic, teeth

Public Device Record Key

850585ba-d6c4-4344-8cde-058c3c6378d7

Public Version Date

October 25, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10304040000868

Quantity per Package

13

Contains DI Package

00304040000861

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

KIT