Catalog Number

-

Brand Name

Clear Guide SCENERGY

Version/Model Number

CGSCENERGY

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K153004,K153004

Product Code

JAK

Product Code Name

System, X-Ray, Tomography, Computed

Public Device Record Key

4b8736c5-2180-4cc9-a0a5-2e3ac0689678

Public Version Date

October 07, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

B201CGSCENERGY1

Quantity per Package

1

Contains DI Package

B201CGSCENERGY0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-