Catalog Number

SHZ-035-010-22

Brand Name

VISICOIL MR

Version/Model Number

SHZ-035-010-22

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

16b3a8be-f959-4551-b80d-1880d36fbd28

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-