Catalog Number

-

Brand Name

Ti DG1

Version/Model Number

UK82665

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

771fe650-bbcf-4501-a950-6e83eced1abd

Public Version Date

August 09, 2019

Public Version Number

2

DI Record Publish Date

December 18, 2018

Package DI Number

15057078000038

Quantity per Package

6

Contains DI Package

05057078000031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton