Catalog Number

213015-LVIS

Brand Name

LVIS

Version/Model Number

213015-LVIS-D-PMA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

-

Product Code

QCA

Product Code Name

Intracranial Coil-Assist Stent

Public Device Record Key

422aa4cf-e372-4617-a102-6e65d564a9dc

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

June 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-