Catalog Number

300843

Brand Name

DTX Studio™ Implant

Version/Model Number

3.3

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 05, 2019

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

K163122

Product Code

LLZ

Product Code Name

System, image processing, radiological

Public Device Record Key

ddad16fa-d33b-4df6-8bc9-9bf21d00ef4b

Public Version Date

April 29, 2020

Public Version Number

3

DI Record Publish Date

August 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-