Duns Number:114379522
Device Description: TheraMark (Anchorseed with AgX100 - 5 cm) -STERILE
Catalog Number
-
Brand Name
TheraMark™
Version/Model Number
TG7745i
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
K111979
Product Code
KXK
Product Code Name
Source, Brachytherapy, Radionuclide
Public Device Record Key
d239c222-30f3-459f-bf90-f97a55eb66c5
Public Version Date
June 02, 2022
Public Version Number
1
DI Record Publish Date
May 25, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 144 |