Duns Number:036545713
Device Description: 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy nee 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle.
Catalog Number
SNMR-035-010-2215
Brand Name
VISICOIL MR
Version/Model Number
SNMR-035-010-2215
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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
K161724
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
8d1f3260-df27-4dc7-a673-33fc7bfdf788
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 |