Catalog Number

-

Brand Name

Symbia Pro.specta X3

Version/Model Number

11364752

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

KPS

Product Code Name

System, tomography, computed, emission

Public Device Record Key

1f1616e5-3fc0-41f2-a81e-29e6fc4b1909

Public Version Date

November 18, 2021

Public Version Number

2

DI Record Publish Date

June 23, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-