Catalog Number

-

Brand Name

TiMolium Titanium Wire

Version/Model Number

386-519

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DZC

Product Code Name

WIRE, ORTHODONTIC

Public Device Record Key

a924c99f-cc19-4dba-b5f8-e6f5c4349641

Public Version Date

March 23, 2021

Public Version Number

1

DI Record Publish Date

March 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-