Catalog Number

-

Brand Name

Titan

Version/Model Number

201102

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"

Yes

For Single-Use

Yes

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

K953889,K953889,K953889

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

10eac0e0-4a26-41bf-a140-48b34c559b35

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 13, 2017

Package DI Number

20817914024787

Quantity per Package

50

Contains DI Package

00817914024783

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

50