Catalog Number

26250-02A

Brand Name

Elements Trajectory Planning Cranial

Version/Model Number

1.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 14, 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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K113732

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

d42025ac-466c-47d4-845b-d4cb33802246

Public Version Date

March 15, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-