Duns Number:036545713
Device Description: 2 - 0.75mm x 0.50cm VISICOIL separated by 20mm PGLA spacer (Stranded with PGLA Sleeve) loa 2 - 0.75mm x 0.50cm VISICOIL separated by 20mm PGLA spacer (Stranded with PGLA Sleeve) loaded in an 18 gauge pre-waxed brachytherapy needle 20cm in length.
Catalog Number
TLS-075-72018
Brand Name
VISICOIL
Version/Model Number
TLS-075-72018
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K120859
Product Code
KXK
Product Code Name
Source, Brachytherapy, Radionuclide
Public Device Record Key
d3c61a8c-1bf1-4aaf-810c-f712eeffb912
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
May 26, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 380 |