Catalog Number

GF1004

Brand Name

Gold Fiducial

Version/Model Number

GF1004

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

Yes

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

K070305

Product Code

JAK

Product Code Name

System, X-Ray, Tomography, Computed

Public Device Record Key

58ccc60a-145f-414d-a229-d4da7db63aba

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

November 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-