Duns Number:036545713
Device Description: 3 Pack - 1.0mm x 5mm Gold Fiducial Marker Loose
Catalog Number
GF1503
Brand Name
Gold Fiducial
Version/Model Number
GF1503
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
K161724,K161724
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
9db14c5f-ecb4-46f9-a76d-bd4fc8a77a0e
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 17, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 380 |