Duns Number:351991547
Device Description: Fiducial Gold Marker. (1) Gold Anchor Marker 0.40x10 mm pre-loaded in (1) Fine Needle 20G Fiducial Gold Marker. (1) Gold Anchor Marker 0.40x10 mm pre-loaded in (1) Fine Needle 20G 0.9x200 mm.
Catalog Number
0038
Brand Name
Gold Anchor
Version/Model Number
GA200X-10-B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K160209,K160209
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
d75f44b6-0077-43a5-850a-1f97111cdfac
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 12, 2016
Package DI Number
07340145700391
Quantity per Package
10
Contains DI Package
07340145700384
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |