Duns Number:114379522
Device Description: Loose TheraStrand with 1-6 seeds, standard spacing for CN
Catalog Number
-
Brand Name
TheraStrand® with TheraSeed®
Version/Model Number
XX72xL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 07, 2016
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
K043596
Product Code
KXK
Product Code Name
Source, Brachytherapy, Radionuclide
Public Device Record Key
02806ff0-9c7e-42e9-a27a-d41a63ec5320
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2015
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 |