Duns Number:036545713
Device Description: Qty 2 - 0.75mm x 0.5cm Gold VISICOILS 15mm Spacer 18g x 20cm Needle2 - 0.75mm x 0.50cm VIS Qty 2 - 0.75mm x 0.5cm Gold VISICOILS 15mm Spacer 18g x 20cm Needle2 - 0.75mm x 0.50cm VISICOIL separated by a 15mm PGLA spacer (Non-Stranded) loaded in an 18 gauge pre-waxed brachytherapy needle.
Catalog Number
TL-075-21518
Brand Name
VISICOIL
Version/Model Number
TL-075-21518
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
0b28ae3a-6212-46e2-b3c7-39d090bf37c9
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 30, 2020
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 |