Catalog Number

VC-050-010-PLSL

Brand Name

VISICOIL

Version/Model Number

VC-050-010-PLSL

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

9aa38abd-9128-404c-badb-89ecee6f1d5a

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

-