Catalog Number

TLS-075-31518-12

Brand Name

VISICOIL

Version/Model Number

TLS-075-31518-12

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

8b9dd0c7-4256-46e4-9e7f-083c7d300861

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

-