Catalog Number

-

Brand Name

Ti DG1

Version/Model Number

UK2035

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

EJH

Product Code Name

Alloy, Metal, Base

Public Device Record Key

be6369f6-4857-42fd-bbea-fc4253206140

Public Version Date

April 20, 2018

Public Version Number

1

DI Record Publish Date

March 20, 2018

Package DI Number

15057078000014

Quantity per Package

3

Contains DI Package

05057078000017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton