Duns Number:964053560
Device Description: BRACHYTHERAPY
Catalog Number
-
Brand Name
GOLD MARKER NEEDLE
Version/Model Number
GM0833-1820
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K103449,K103449,K103449,K103449
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
60964a22-7b9b-4d97-9979-044229cb72ad
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
October 24, 2015
Package DI Number
30812444022231
Quantity per Package
9
Contains DI Package
00812444022230
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 12 |
2 | A medical device with a moderate to high risk that requires special controls. | 1369 |
U | Unclassified | 8 |