Duns Number:036545713
Device Description: 1.10mm x 0.5cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle.
Catalog Number
VC-110-005-PL
Brand Name
VISICOIL
Version/Model Number
VC-110-005-PL
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
K070305
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
2073af44-5424-41e1-86b0-e62a26fbfd07
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 |