Catalog Number

172537-LVISJ

Brand Name

LVIS Jr.

Version/Model Number

172537-LVISJ-C-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

a587e197-8beb-420d-851a-96b4266f0df5

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

-