Duns Number:351991547
Device Description: Fiducial Gold Marker. (1) Gold Anchor Marker Pure Gold 0.40x10 mm pre-loaded in (1) Fine N Fiducial Gold Marker. (1) Gold Anchor Marker Pure Gold 0.40x10 mm pre-loaded in (1) Fine Needle 22G 0.7x200 mm.
Catalog Number
0010
Brand Name
Gold Anchor
Version/Model Number
GA200-10-BG
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
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
K091645,K091645
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
1e764706-21c4-4f95-b35f-12cc574d415a
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
June 08, 2016
Package DI Number
07340145700117
Quantity per Package
10
Contains DI Package
07340145700100
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 |