Catalog Number

90-1046

Brand Name

Triton

Version/Model Number

90-1046

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K110481

Product Code

EIA

Product Code Name

Unit, Operative Dental

Public Device Record Key

b7dd008c-7298-4d38-9743-e49c4bc44552

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-