Duns Number:114379522
Device Description: Loose TheraStrand® with 1-6 seeds, standard spacing, in TPSII Ind. for CN
Catalog Number
-
Brand Name
TheraStrand® with I-Seed
Version/Model Number
XX72xiLN
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
1339ba4e-793a-49a2-a0e4-6450f9538afa
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 01, 2016
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 |